Urologic Procedures and Antimicrobial Prophylaxis (2019)
To cite this best practice statement:
Lightner DJ, Wymer K, Sanchez J et al: Best practice statement on urologic procedures and antimicrobial prophylaxis. J Urol 2020; 203: 351.
Published June 2019
Deborah J. Lightner, MD; Mayo Clinic; Kevin Wymer, MD; Mayo Clinic; Joyce Sanchez, MD; Medical College of Wisconsin; Louis Kavoussi, MD; Northwell Health
Table I: Host–related factors affecting SSI risk a[pdf]
Table II: Proposed Procedure–associated Risk Probabilty of SSI c,d,e,f [pdf]
Table III: Recommended Definitions for a Surgical Site Infection (SSI), Hospital Acquired Infection (HAI), and Periprocedural Urinary Tract Infections (UTI) b,c,d [pdf]
Table IV: Wound Classifications k [pdf]
Table V: Recommended antimicrobial prophylaxis for urologic procedures [pdf]
Table VI: End of Case Assesment of Wound Class f [pdf]
The primary rationale for antimicrobial prophylaxis (AP) is to decrease the incidence of surgical site infection (SSI) and other preventable periprocedural infections, with the secondary goal of reducing antibiotic overuse. Despite the availability of a comprehensive guideline outlining AP for general surgical procedures (revised in 2017) 1 and the American Urological Association (AUA) Best Practice Statement (BPS) Urologic Surgery Antimicrobial Prophylaxis (published in 2008 and reviewed in 2011), 2 tremendous variability in clinical practice persists, with known variation from hospital to hospital and provider to provider. 3-5 The absence of strong evidence to support such variations, rapidly changing paradigms in periprocedural prophylaxis, and an unmet need for practice standardization for common clinical scenarios necessitate further update of the AUA BPS.
Much has changed in AP in recent years, with specific concerns regarding minimizing infectious complications in patients with community versus nosocomial acquired colonization; those with anaerobic 6 or gram-positive organisms, 7 which are not covered by standard genitourinary (GU) prophylaxis regimen; those with previously placed indwelling stents and catheters; 8 or those recently prescribed antimicrobials given that increasing resistance to common pathogens may occur after a single dose of a fluoroquinolone. 9 Such concerns are magnified by the urgent need for enhanced antimicrobial stewardship worldwide wherein antimicrobials are rapidly diminishing in their coverage for common pathogens, and where adverse event risk reduction is paramount. 10 The benefits of compliance with AP guidelines are clear and have been shown to reduce both pathogen resistance and costs; 11 as such, urologists’ knowledge of AP must be continually updated in this rapidly evolving field.
Looking beyond the adverse effects ascribed to the drug itself, it is acknowledged that there is difficulty in risk/benefit assessment of AP as any potential benefit accrues to the patient, whereas only risks (and no benefits) are applicable to the larger community. As such, further research is required incorporating community and hospital antimicrobial resistance patterns. Additionally, isolation of selected variables may require animal and in vitro studies rather than population studies.
Beyond the rapid changes in antimicrobial resistance patterns and antimicrobial stewardship concerns, there remains much debate on the use of single-dose regimen in urology, specifically in the setting of indwelling catheters and stents outside the immediate perioperative period. There is little high-quality literature on this subject.
Many clinical questions remain unanswered regarding AP. Of particular concern is the inappropriate use of bacteriuria as an endpoint for periprocedural infectious complications in the literature rather than standard definitions established for infectious complications. Another is the significance of differing levels of compliance with AP in relation to changes in the rate and severity of periprocedural infections. For example, while compliance with AP measures enumerated in The Surgical Infection Prevention and Surgical Care Improvement Projects: National Initiatives to Improve Outcomes for Patients Having Surgery12,13 reduced the SSI risk by 18%, 14 increasing compliance with this measure alone did not closely correlate with the resulting decreases in infectious complications rates. 15 Other aspects, such as glucose monitoring and normothermia, concurrently incorporated into surgical care improvement projects certainly contributed to these risk reductions. 16 Further, there are differences between the classifications of surgical complications with the Clavien-Dindo classification scoring a complication differently than the Centers for Disease Control and Prevention (CDC) recommendations. 17 Lastly, it is unlikely that high volume data on SSI and the impact of AP will be available in the near term for most urologic procedures; SSI are currently reported for inpatient hospital procedures, and most urology cases are increasingly performed as 23-hour stays or less. Currently, no widely accessible registry base exists for these SSI that occur in the outpatient setting, unless secondarily reported with major complications such as requiring a return to the operating room.
This BPS strongly recommends that future studies use standardized definitions of SSI 18,19 suggested in Table III as outcome measures, even as healthcare professionals work to determine the best definitions within specialties and procedures. 20 The literature must also continue to push towards validation of the various SSI risk prediction models 21 with correlation against actual SSI rates for specific urologic cases. This will require that outpatient and short stay procedures are broadly considered and specifically assessed for the risk-benefit of AP.
While a complex topic, this BPS is intended to be a comprehensive and user-friendly reference for the clinicians and providers caring for patients undergoing urologic procedures. As such, the BPS will generously reiterate statements from rigorously developed guidelines and incorporate them into a single comprehensive source on this topic for urologic practice. Further research should help delineate these recommendations where high-level evidence is lacking.
The Panel recognizes that this BPS will require continued literature review and updating as further knowledge regarding current and future options continues to develop in a rapidly changing area.
When planning a procedure or surgical intervention, one must consider the principles of infectious disease prophylaxis, which examine the questions: who, what, where, and when. Accordingly, this BPS included patient risk factors (who); diagnostic and treatment-associated urologic procedures, GU surgery, and prosthetics (what and where); as well as AP timing, re-dosing, and duration (when) in the search criteria. The search did not include the evaluation and management of infections outside the GU tract, asymptomatic bacteriuria (ASB), nor clinically suspected but microbiologically unproven symptomatic infections. Also excluded from the search are pediatric urologic procedures, and, although a paper evaluating pediatric AP is recommended, it was excluded from this document due to the differing risk factors on antimicrobial dosing for pediatric AP. Prostate biopsy and periprocedural management of stones were likewise excluded; however, relevant guideline recommendations and white paper statements current at the time of this publication are included and referenced. Similarly, bowel preparation and open or laparoscopic surgery are incorporated from the General Surgery and Colorectal Surgery Guidelines. 22,23 The BPS on urodynamic AP from the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 24 is incorporated into this document. Lastly, some statements included here are frequently based on expert opinion if high-level evidence is lacking or if they pertain to the non-index patient. The weakness of the evidence for many of these recommendations should be interpreted as meaning that these recommendations are subject to change as stronger evidence becomes available.
1. Periprocedural antimicrobial prophylaxis for the reduction of surgical site infections may be considered for all urologic procedures where a break in normal tissue barriers will occur.
A single dose of an antimicrobial, which may reduce the risk of SSI, may be considered for incisions in the skin, including simple bladder biopsies and vasectomies. There are no randomized controlled trials (RCTs) comparing appropriate preoperative and intraoperative site preparation and sterile technique to good surgical practices with AP. Simple outpatient diagnostic tests, which do not normally break either the mucosal or skin barrier, likely do not require AP in the healthy individual. 25,26 The practice of AP is being increasingly questioned in these clinical settings, including both adult and pediatric Class I/clean procedures 25 (see Table IV).
2. Antimicrobials should not be used except where medically indicated. Systemic antimicrobial usage is the primary driver of antimicrobial resistance both in the index patient and the community.
Cases that may safely be performed without AP should rely on good sterile techniques rather than AP. Systemic antimicrobial usage is the primary driver of antimicrobial resistance both in the index patient and the community. Limiting AP to cases when it is medically indicated will reduce the risks of antimicrobial overuse, which include patient-associated adverse events, 10,27-32 the development of multidrug resistant (MDR) organisms, 33 and the impact of MDR on recovery from common community-acquired infections. 33 Those urologic cases that might forgo AP include all Class I procedures and many Class II procedures (see Table II).
3. The choice of periprocedural systemic antimicrobial agent(s) to reduce the risk of post-procedural surgical site infections and systemic infections should be carefully considered for any invasive procedure. The use of any antimicrobial should consider the patient’s medical risks and allergies and the inherent risks associated with antimicrobial prophylaxis chosen. 29
All antimicrobials have the potential for causing adverse reactions. While allergy to penicillin and other β-lactams are among the most frequent drug reactions reported, patients will frequently report non-allergic phenomenon as a drug reaction. Testing for true allergy is appropriate with this class of antimicrobials considering it is likely to be required for current and future care. Referral to an allergist or other specialist is warranted in these cases. 29 The use of penicillin and β-lactams in the setting of a true Type I hypersensitivity reaction is contraindicated due to the risks of anaphylaxis and death. 34
The U.S. Food and Drug Administration issued multiple Boxed Warnings regarding serious musculoskeletal, peripheral neuropathy, mental health, and most recently, hypoglycemic coma treatment-emergent adverse effects (TEAE) due to fluoroquinolones. Consequently, their use as first-line treatment of uncomplicated cystitis is discouraged; use of such agents should be reserved for serious bacterial infections where the benefits outweigh the risks. To date, there is no clear evidence to suggest these TEAE occur with single dose prophylaxis; however, many practices are using alternative agents when possible. Additionally, there has been a steady increase in resistance rates of Escherichia coli to fluoroquinolones. Ultimately, patient specific factors and local antimicrobial susceptibilities, as reflected in local antibiograms, should influence choice of agent. Within urologic practice, transrectal prostate biopsy may still require consideration of fluoroquinolone AP in some centers and in some clinical conditions. 35
4. The potential benefit of antimicrobial prophylaxis should be considered with assessment of five points: 1. the patient’s ability to respond to an infection, 2. the procedure being performed, 3. procedural factors that increase the likelihood of bacterial invasion at the operative site, 4. the virulence of the bacterial pathogen, and 5. the potential morbidity of any subsequent infection. The morbidity of antimicrobials includes the potential treatment emergent adverse events and the development of drug resistance.2
Several host factors play into the determination of the patient’s risk of acquiring an infection. Immunosuppression is a well-known risk for developing infectious complications. For example, macrophages, concentrated in the spleen, are responsible for clearance of encapsulated bacteria. Thus, splenectomized patients are at greater risk of developing infectious complications with encapsulated organisms including Streptococcus pneumoniae, Group B streptococcus (GBS), Klebsiella spp, Neisseria spp, and some strains of E. coli. Depressed B-cell function occurring with chronic use of steroids and other immune modulators increases risk for infections with pyogenic bacteria, fungi, and parasites. Neutropenic patients are at risk for bacterial sepsis from both gram-positive and gram-negative organisms, especially Pseudomonas species. Host-related abilities to defend against bacterial invasion are also related to the local environment, including the preservation of the cell wall barrier, local tissue oxygenation, healthy vascularity and lymphatic drainage, and more recently recognized, the host’s own microbiota profile. 36,37 Patient risk factors can also be estimated by surrogate measures such as the patient’s overall preoperative anesthetic risk, as measured by the American Society of Anesthesiologists status, smoking status, nutrition (albumin less than 3.5 mg/dL), and periprocedural immunosuppression 15 (Table I).
Other host-specific factors such as drug allergy, intolerance, or a history of Clostridium difficile infection may influence the selection of an antimicrobial agent for prophylaxis. Recent or current antimicrobial therapy for another indication would also need to be considered, as it is preferable to select an antimicrobial of another class due to the likely change in the microbial flora and susceptibilities. For example, if the patient had recently taken a course of a cephalosporin, prophylaxis with a sulfonamide would be more appropriate than another cephalosporin.
The procedures themselves may be classified into low-risk, intermediate-risk, and high-risk probability for an associated SSI (Table II). For instance, a neutropenic patient undergoing a simple cystoscopy may require AP, whereas a healthy patient does not. A healthy patient undergoing urinary diversion with large bowel segments requires AP. Risk classification herein is dependent on the likelihood of SSI, not the associated consequences of an SSI. For example, while the risk of SSI with prosthetic materials and devices is intermediate, the consequences of an SSI in this setting is high.
There are modifiable perioperative factors affecting SSI risk, which include the avoidance of hypothermia, blood glucose control, preoperative bathing and skin preparation, and sterile technique. The degree of mucosal injury, the surgical wound classification, and the duration of the procedure impact risk of a periprocedural infection. 38,39 For example, a clean minimally invasive procedure of short duration with perioperative sterile urine is less likely to result in a periprocedural infection than their opposites. While wound closure techniques, 40 timing of showers, and dressing removal do not appear to impact the risk of SSI, the urgency and complexity of the surgical procedure and any associated breaks in infection-control protocols 15 do change the risk. Periprocedural infections are not limited to the surgical site, and other healthcare-associated infections may occur, such as periprocedural pneumonia and catheter-associated urinary tract infection (CAUTI).
While most bacteria possess the capacity to cause disease, the ability to do so (pathogenicity) varies by organism and its speciation. As an example, most urinary tract infections (UTIs) are caused by uropathogenic E. coli, but not enteric E. coli commonly associated with diarrhea. Virulence, an expression of an organism’s pathogenicity, is complex. Virulence factors include vector-produced lipopolysaccharides, proteins, and/or carbohydrates that might promote bacterial attachment, such as diffusely adherent E. coli, those that enclose and protect the bacterium from attack, toxins capable of inciting a counterproductive inflammatory response, or proteolytic enzymes and other products that attack the host organisms’ defenses and are thereby capable of subverting the host’s metabolic processes.
5. Single-dose antimicrobial prophylaxis is appropriate in the majority of uncomplicated urologic cases.
The current era of increasing healthcare-related costs, adverse events, and growing MDR calls for use of antimicrobials only when medically necessary and with the narrowest spectrum of activity with the shortest duration possible. This ensures the best care for both the patient as well as the greater health of the public. There is no high-level evidence to support the use of multiple doses of antimicrobials in the absence of preoperative symptomatic infection. Furthermore, there is moderate-quality evidence from multiple RCTs that do not show a benefit of prolonging AP beyond the case completion, 41 and, according to a World Health Organization (WHO) systematic review, the benefit of intraoperative coverage is undetermined at this time. 42,43
Antimicrobial stewardship programs, which will provide improved support and guidance to physicians on proper antimicrobial use, monitor the local antimicrobial resistance patterns and reevaluate these patterns every 6 to 12 months. Such programs have become a requirement for hospitals and clinics in the United States. With the aid of such tools, the clinician should be aware of the local antibiogram for resistance patterns for the likely pathogens occurring with urologic procedures.
More recent guidelines recommend that only a single dose of preoperative AP be used and that there be no postoperative continuation without exceptions for surgical procedure type. 45-48 The 2006 Surgical Care Improvement Project, 44 the Infectious Diseases Society of America (IDSA), the United States Institute of Healthcare Improvement, the American Society of Health Care Pharmacists, and the Society for Healthcare Epidemiology of America have each recommended discontinuing AP within 24 hours after surgery. 40,41 The concerns regarding limiting AP doses beyond wound closure is not unique to urologic practice. The current recommendations that AP is to be given preoperative and no additional dosing beyond the closure of the procedure are recommended for intravascular lines and devices, surgical drains, and stents. Clinically, vascular graft placement and prosthetic devices commonly are treated with less than 24 hours of AP coverage. It should be noted there is only low-quality evidence supporting a benefit of up to 24 hours of AP compared to no additional dosing after case completion, whereas there is a defined risk as AP continuation beyond a single perioperative dose has been associated with a 4.5% risk of subsequent clostridial infections in one RCT. 49 While no surgical study has evaluated the resultant MDR patterns emerging from single-dose AP compared with no antimicrobials, the use of prolonged antibiotic prophylaxis (>48 hours post-incision) has been significantly associated with an increased risk of acquiring antibiotic-resistance, while conferring no decrease in SSI. 50 Hence, in the absence of high-quality research to suggest a benefit to continued AP beyond wound closure and literature to suggest specific harms, this BPS recommends that AP be limited to the duration of the procedure itself with no subsequent dosing after wound closure.
6. Single-dose antimicrobial prophylaxis coverage for usual skin flora may not be necessary for skin incisions Class I/clean procedures (uninfected, no inflammation, closed primarily without entrance into the gastrointestinal or genitourinary tracts). Exceptions are appropriate for prosthetic device implantation and may be considered for groin and perineal incisions where the surgical site infection risk may be increased.
Implicit in risk reduction is the understanding of the baseline risk. Due to the long-standing practice of perioperative AP, the contemporary baseline rate of infectious complications without antimicrobial treatment is available for very few procedures. 51 Recent studies of Class I/clean outpatient urologic procedures 47 including minimally invasive surgery (MIS) for renal and adrenal tumors, 36 arteriovenous fistula, and graft creation, 32 as well as some Class II/clean contaminated procedures, such as ureteroscopy, 52 have not demonstrated a significant benefit of AP. Selective use of AP for higher-risk individuals is encouraged. 53
The reported risk of either superficial or deep SSI for a Class I/clean procedure in the absence of identifiable host-related risk factors is approximately 4%. The risk for a remote infection (as defined by CDC 1999) for Class I/clean procedures is similarly relatively low, between 2.7% to 4%, but both SSI and remote infection increase with increasing risk as measured by the National Nosocomial Infectious Surveillance (NNIS) risk index 54 for these Class I wounds. These risks include American Society of Anesthesiologists physical status classification greater than or equal to 2, and length of procedure >3 hours. 55 Recent modifications to the NNIS risk index include a history of preoperative chemotherapy (OR=1.94), or groin incisions (OR=4.65). 56 As groin, and presumably perineal incisions, may confer an increased risk of SSI, single-dose AP may be considered for these cases. 57,58
For prosthetic device implantation, AP coverage for skin flora, specifically coagulase negative staphylococci and also gram-negative bacilli, including Pseudomonas species, has been recommended. 69 Of note, recent studies have demonstrated decreasing overall incidence of prosthetic infection; however, relatively higher rates of anaerobic, methicillin-resistant Staphylococcus aureus (MRSA), and fungal infections are potentially being identified when infections do occur. 59,60 Periprocedural surgical techniques are important in reduction of colonization and positive surgical cultures in artificial urinary sphincter placement; however, a correlation with periprocedural infectious complications was not able to be deduced due to the low prevalence of SSI. 61 There remains a significant lack of consistent practice for AP for prosthetic devices in duration, agent, and the use of antibiotic soaking or wound irrigation at the time of placement where currently only low-level evidence exists. Studies are urgently needed as the risk of prolonged antibiotic courses and of the use of vancomycin are considerably higher than with short-course first-generation cephalosporins. Similarly, the efficacy of irrigation in the absence of prosthetic infection or erosion is currently being studied, as are methods for the reduction of biofilm. 60 Future SSI reduction strategies clearly need to assess the organisms grown at explant of infected prostheses to direct future guidelines in this critical area. 59
7. Single-dose periprocedural antimicrobial prophylaxis is currently recommended for patients undergoing specific Class II/clean-contaminated genitourinary procedures as the risk reduction of a serious surgical site infection or systemic infection exceeds the anticipated risks of increasing antimicrobial resistance and other adverse events. Routine cystoscopy and urodynamic studies do NOT require antimicrobial prophylaxis in healthy adults in the absence of infectious signs and symptoms.
Class II procedures include those entering into pulmonary, gastrointestinal (GI), or GU under controlled conditions and without other contamination. For urologists, these include any opening into the GU tract, nephrectomy, cystectomy, endoscopic, and vaginal cases. The reported risks of a periprocedural infectious complication for Class II/clean-contaminated GU procedures range considerably even with appropriate AP covering the most likely pathogens, and underscore the variability of procedural-specific risk of SSI.
Class II/clean-contaminated urologic procedures are not categorized by SSI risk but by broad wound class definitions. Unfortunately, as the urologic procedure-associated risks of an SSI do not align with these traditional wound classifications (Table IV), these classifications should not be used to determine the need for AP. For example, a cystoscopic examination, defined as a Class II procedure, has an extremely low risk of SSI compared with transurethral resection of the prostate (TURP), another Class II procedure. AP for Class II/clean-contaminated urologic procedures needs to be tailored to the specific procedure-associated risk. While the need for AP for urologic Class II procedures is based on the specific procedure, the AP agent choice requires knowledge of the prior urine culture results, the local antibiogram, and the patient’s associated risks. 62,63
AP is not recommended for simple outpatient cystoscopy and/or urodynamic procedures, catheterization, or catheter changes. The use of AP in these circumstances must be individualized to patient risk. Gregg et al. have demonstrated no increase in infectious rates using an evidence-based protocol to select those undergoing outpatient cystoscopy who are at highest risk of an infectious complication and thereby, limiting AP specifically to those individuals. 53 Those risk criteria are included in Table I.
Single-dose AP is recommended prior to all procedures for the treatment of benign prostatic hyperplasia (BPH), transurethral bladder tumor resections, vaginal procedures (excluding mucosal biopsy), stone intervention for ureteroscopic stone removal, percutaneous nephrolithotomy (PCNL), and open and laparoscopic/robotic stone surgery (see Table IV). These more invasive procedures entail higher SSI risk.
Assuming both a benign current urinalysis and the absence of symptoms attributable to a UTI, periprocedural coverage for gram-negative enteric pathogens and enterococci is recommended for both transurethral procedures and therapeutic upper endoscopic procedures. Current recommendations include first- and second-generation cephalosporins, or trimethoprim/sulfamethoxazole as a single dose. Enterococcal coverage remains primarily penicillin or ampicillin where the community rates of vancomycin-resistant enterococcus (VRE) are low. While often effective against VRE, the use of nitrofurantoin or fosfomycin as coverage for possible enterococcal AP is not recommended due to the poor tissue concentrations achievable with those agents.
Of the β-lactams antibiotics, extended-spectrum penicillins and amoxicillin are widely used for AP for gram-negative rod (GNR) coverage. However, fourth-generation penicillins (caroxypencillins, such as ticarcillin, or ureidopeniciliins such as piperacillin and mezocillin) should generally be reserved for specific clinical indications. Good AP coverage is provided for common GNR with the first- and second-generation cephalosporins. However, both Serratia and Providencia GNR are now widely MDR organisms. Proteus species, often associated with infectious stone disease, are variable in their antibiotic sensitivities with most Proteus spp. still inhibited by penicillins; however, aminoglycosides and cephalosporins are also appropriate for most GU cases requiring AP.
Vaginal procedures should consider additional anaerobic coverage, which is most often afforded by the use of a second-generation cephalosporin, such as cefoxitin. An SSI associated with a vaginal hysterectomy is often polymicrobial; without antimicrobial coverage, SSI incidence ranges widely from 14% to 57%. AP coverage, therefore, should cover the pathogens most frequently isolated in hysterectomy-associated SSI, which include aerobic gram-negative bacilli, and Bacteroides species, again with a single dose of a second-generation cephalosporin. Ampicillin-sulbactam may also be used as second-line, which improves enterococcal coverage. Additional anaerobic coverage provided by metronidazole and an antifungal such as fluconazole may also be considered for vaginal cases, particularly for high-risk patients.
Again, the wound classification of Class II/clean-contaminated is a continuum of procedures ranging from lower risk (e.g. cystoscopy) to those with a high risk of SSI (e.g. endoscopic procedures for benign prostatic hypertrophy). In lower-risk Class II/clean-contaminated procedures such as office cystoscopy, AP does not provide a risk/benefit ratio supporting routine AP use. 53,64-67 Emerging data suggest that antibiotics may not be medically necessary for simple bladder biopsies performed with periprocedural uninfected urine. The rate of simple UTI or febrile UTI was approximately 1% in 216 biopsies either without or with appropriately-chosen AP. 68 These lower-risk Class II procedures should be stratified by patient-associated risks to safely reduce the risks associated with inappropriate AP.
Future investigations are encouraged that would allow subclassification within specific Class II procedures by patient and periprocedural risk characteristics, and inclusive of SSI and remote infections. As examples, patients undergoing urologic procedures often have associated host-related factors that increase the risk of an SSI and bacteremia; a recent TURP study found that ASB occurred during the case in 23% of patients. Notably, there is often overlap in these patient and procedural risks: the majority of these TURP patients had preexisting risk factors, including 50% with indwelling catheters prior to the procedure. 69
8. Single-dose antimicrobial prophylaxis agents are recommended for patients undergoing Class III/ contaminated procedures as the risk of a serious surgical site infection or systemic infection is high. Specific Class III/contaminated procedures requiring antimicrobial prophylaxis include transrectal prostate biopsy.
For Class III wounds, those including infectious stones and the use of bowel segments, the risk reduction of a periprocedural infectious complication is considerable. Consistent with the larger body of the literature, one study demonstrated a risk reduction from 39% to 13% with appropriately selected AP. 70 The risk of SSI and ssepsis in the healthy individual is considerable with transrectal prostate biopsy; as such, AP is mandatory in this clinical setting. In Class III/contaminated cases, the surrounding tissue is exposed to pathogens routinely.
Similar to Class II procedures, there is emerging data that Class III wounds vary in the associated SSI risk. For example, single-dose AP may not be required for surgical incision and drainage. 71 For surgical procedures including unobstructed small bowel, patients should receive a first-generation cephalosporin (cefazolin) as the upper GI tract flora is relatively sparse and intense colonization unusual in the healthy individual. 72 This simple regimen is not appropriate in obstructed small bowel nor with prior bypass nor biliary stenting. Population-based studies of infectious complications after AP for radical cystectomy similarly demonstrated that first-generation cephalosporins were most commonly used, but the authors noted that only 15% of patients received AP consistent with the current guidelines. 73
For surgical procedures including the colorectum, the bacterial flora is extensive, and the predominant organisms are anaerobic. Hence, for patients undergoing colorectal surgical procedures, coverage for both aerobic and anaerobic organisms is required; a first-generation cephalosporin and anaerobic coverage with metronidazole (which remains active against B. fragilis). Anaerobic coverage is critical in SSI reduction; the use of a single-agent first-generation cephalosporin, for example, without additional anaerobic coverage for a colorectal case increases the risk of a SSI from 12 to 39%. 74 While the use of second- or third-generation cephalosporins can provide moderately effective anaerobic coverage, with SSI rates in multiple trials ranging from 0 to 17%, 44 the use of third-order and higher generation cephalosporins is associated with higher resulting MDR patterns and should be reserved for culture-specific indications and not for routine AP. Where institutional gram-negative enteric resistance patterns to first- and second-generation cephalosporins is high, the use of a single dose of ceftriaxone, (a third-generation cephalosporin) plus metronidazole may be preferred over routine use of carbapenems (e.g., imipenem, ertapenem), which are more specifically reserved for targeting MDR organisms. Other combinations for colorectal AP have included ampicillin–sulbactam or amoxicillin–clavulanate, both reported in small studies to be as effective in reducing SSI as have combinations of gentamicin and metronidazole, gentamicin and clindamycin, and cefotaxime and metronidazole. 74
Preoperative mechanical bowel preparation and oral antibiotics for colorectal procedures is recommended (based on moderate-quality evidence from 1990 through 2015) by the WHO, 75 consistent with most urologic practices using colorectal segments22 and associated with reduced complication rates. 23 The use of small bowel segments for diversion does not necessitate a bowel prep. 76,77
Alternative agents for all Class III procedures, such as for patients with a history of allergy or other adverse event to β-lactams, include either a triple drug combination of clindamycin or vancomycin, an aminoglycoside, and aztreonam or a two-drug regimen with metronidazole plus an aminoglycoside. Of note, past recommendations included the use of fluoroquinolones; however, this BPS does not.
9. Class IV wounds are by definition infected. Antimicrobial prophylaxis guidelines may help choose the most appropriate empiric antimicrobial agent(s) for the most common offending pathogens until cultures inform targeted therapy.
Similarly, if intraoperative circumstances change and a wound becomes or is recognized as, contaminated, a shift up in AP coverage should occur. As examples, if purulence is discovered at the time of a routine stent exchange, then cultures should be obtained and the antimicrobial agent(s) continued until the culture results are known. If large bowel spillage occurs at the time of a reconstruction, then anaerobic antibiotic coverage is now indicated. Wound classification, therefore, is best considered a flexible designation throughout the case. If contamination occurs, then the wound class changes and the AP agent(s) should be reconsidered.
10. Surgeons should define and document any surgical site infection when it occurs using standardized definitions of surgical site infection.
Standardized definitions for SSI, sepsis, and post-procedural UTI (see Table III) should be used for reporting by the surgeon, who is the most accurate observer of the wound class and of any subsequent infectious complications. The current literature provides little on the frequency of true infectious complications for most surgical procedures as many complications are underreported or surrogate measures have been used. The documentation of SSI associated with outpatient and short-stay procedures is inadequate as illustrated by an older study that reported that 84% of SSI occurred after discharge and, therefore, were underreported. 78 Likewise, surrogate end points are often the presence or absence of bacteriuria or colonization rather than an explicit infectious complication. The development of bacteriuria after GU instrumentation is not an appropriate clinical endpoint for SSI as it is not a relevant clinical outcome correlating with a defined complication. As examples, a placebo-controlled RCT of 120 patients undergoing TURP with sterile urine were randomized to a first-generation cephalosporin or a third-generation cephalosporin, but the outcome of the study was bacteriuria and not an infectious complication. 79 The subsequent development of bacteriuria occurs in approximately 8% of women undergoing lower urinary tract instrumentation; however, this low-level incidence is not relevant in prediction of infectious complications. Similarly, other studies have used colonization as an endpoint rather than infectious complications when the prevalence of an SSI is low at baseline. 61
11. Parenteral antimicrobial prophylaxis agents should be administered within one hour of an incision to establish an appropriate bactericidal concentration of the agents in the tissues at the time the incision is made. If used, vancomycin and fluoroquinolones may be administered within two hours of the procedure.
Periprocedural AP should be limited to a single dose directed towards likely organisms and achieving tissue levels prior to the surgical start to maximize benefit and reduce risks. It is now an established norm, albeit based on intermediate-strength evidence, 80 that AP should be delivered within one hour of the incision. Two hours should be allowed in the case of vancomycin and fluoroquinolone use. The least amount of antimicrobials needed to safely decrease the risk of infection to the patient should be used in order to minimize antimicrobial-related adverse effects and decrease the risk of drug-resistant organisms. This is consistent with the definition of prophylaxis. Although controversial in the percutaneous treatment of upper tract stone disease, 80 AP is not required days before, nor even the night before a procedure. Selection of antimicrobials is best influenced by how well the agent penetrates the tissues/compartment of interest and is at minimum inhibitory concentrations or above at the time of the procedure. For this reason, nitrofurantoin is a poor agent for AP due to low tissue concentrations, although it is highly concentrated in the urine.
Oral antimicrobials are often selected for AP due to cost savings and ease of availability. It must be emphasized that for oral administration, the achievement of adequate tissue levels of the selected antimicrobial may not occur within the one-hour time frame given for parenteral administration. For example, sulfamethoxazole-trimethoprim time to peak for an oral dose is one to four hours, 82 for ciprofloxacin it is one to two hours, 83 and for cefdinir is two to four hours. 84
12. Antimicrobial prophylaxis should target the likely local organisms. For example, incisions into the urinary system should be covered by antimicrobials whose profile covers the most recent local antibiogram for genitourinary organisms. Cost, convenience, and safety of the agent as well as impact on emerging resistant organisms should be considered.
Different anatomic sites have distinct native flora, impacting the likely organisms that may pose risk to the patient. For cutaneous incisions where a prosthetic device is planned, coverage for skin flora including streptococci is warranted. For higher-risk procedures entering the GI tract, coverage of common gram-negative urogenital flora should be administered. For procedures that enter the large bowel, gram-negative and anaerobic organisms pose a risk to patients.
The patient’s biome plays a role in the proper selection of AP: patients with colonization with MRSA may need an additional agent for reduction of invasive MRSA skin/soft tissue infections. Screening for MRSA is controversial in low-risk populations; some centers will screen high-risk populations (e.g., institutionalized patients) undergoing procedures where the potential morbidity of any subsequent infection is high, 85 or those entering high-risk environments (e.g., intensive care units). 86 Patients with a known history of MDR organisms may warrant more expanded antimicrobial coverage for those procedures requiring AP. Patients with a history of C. difficile infections should be closely monitored for recurrence, and the agent for prophylaxis should be carefully chosen. The current evidence strength regarding successful strategies to reduce periprocedural C. difficile infections is weak. 89
Clinicians should understand the institutional and regional variations 88 in antimicrobial sensitivities that impact prophylaxis and guide the course of AP accordingly. Those residing in a healthcare facility, or having had a recent intensive care unit stay 89 or a prolonged hospitalization have been associated with higher antimicrobial resistance patterns. Other risk factors for MDR organisms include exposure to antimicrobials within six months and foreign travel. Due to emerging MDR, these recommendations will remain in flux; clinicians are urged to consult their local antibiograms 90 and local infectious disease experts where needed.
The WHO publication recently performed a systematic review on whether screening for infection with potentially harmful organisms or surgical AP should be modified in areas with high (>10%) extended-spectrum β-lactamase producing Enterobacteriaceae prevalence. The systematic review found no high-level evidence with which to answer the question. 41
The type of procedure being performed dictates the prophylaxis. The more invasive the procedure, the more contaminated the operating field, the longer the procedure, the greater the risk of a post-procedural infection. Unfortunately, surgeons have been shown to often be inaccurate in the determination of a specific surgical wound’s classification 91 despite the establishment of definitions almost 20 years ago. 18
Contaminated cases where there are open, fresh, accidental wounds, major breaks in sterile technique, gross spillage from the GI tract, or procedures within acute, but non-purulent, infection, all pose greater periprocedural infectious risk and require antimicrobial treatment rather than simple prophylaxis. 92 Similarly, the dirty case, whether involving debridement, older traumatic wounds with retained devitalized tissue or perforated viscera, requires antimicrobial treatment. The duration and dosing of therapy is mandated by that changed indication for treatment, and not simpler prophylaxis.
Procedures with durations greater than three hours have been found to have a significantly increased risk of SSI; as such, it is now standard practice for re-dosing of antimicrobials if the procedure extends beyond two half-lives of the initial dose. 42 High-level evidence is lacking, but unlikely to be further studied in a RCT.
A more accurate method of accurately capturing the surgical wound classification has been suggested (Table V). The determination of the wound classification at the end of the case is already performed by most operating room health personnel during final case charting. Discussion will provide agreement across the surgical team as to the final wound class as well as a restatement and/or amplification of the AP required. The classical descriptions of clean procedures in which there are no infected areas, where GI, respiratory, genital, or urinary tracts are not entered, pose the least amount of post-procedural SSI risk. Studies have reported the SSI as 0% where AP has been given, and still less than 4% when not used. In the presumed absence of MRSA, a single dose of a gram-positive-covering antimicrobial, such as a first-generation cephalosporin, is the only requirement for clean/Class I cases needing AP. Clean-contaminated areas, those involving GI, respiratory, genital, or urinary tracts under controlled conditions and without unusual contamination, pose a more significant risk. Actual risk rates are poorly defined, highly variable, and dependent upon the trial design, case inclusion, source search and definitions, the population and their associated risks. SSI reports for clean-contaminated wounds ranges from 3% in a tightly case-controlled study of hysterectomies 93 to 9.9% where patients reported having had a UTI after ureteroscopy 94 to 18% with more complex open bariatric, colonic, or gynecologic oncology cases. 95 With major urologic oncologic surgery, 24% of radical cystectomy patients are reported to have developed either a SSI, sepsis, or UTI with operative times greater than or equal to 480 minutes, the strongest independent risk factor. 96
Surgeons, therefore, should consider reclassifying the wound at the conclusion of the case, noting breaks in sterile technique or any inadvertent entry into bowel, urinary or vaginal tract that may have occurred. While this reclassification from Class I/clean to Class II/clean-contaminated would not change the duration of AP and may not necessitate the addition of another antimicrobial agent, the change in the surgical wound classification will improve accurate reporting and monitoring of SSI. 91
13. Surgical antimicrobial prophylaxis may require re-dosing, weight-adjustment, or renal adjustment to ensure desired antimicrobial tissue levels during a procedure.
AP is only effective when the tissue concentrations of the appropriate antimicrobial are maintained above the minimal inhibitory concentration of the possible pathogens throughout the procedure. A known risk of AP failure is inadequate tissue levels due to inappropriate antimicrobial choice, dosing or redosing if a procedure is prolonged.
Searches of published studies have not identified RCTs or systematic reviews that evaluate weight-adjusted AP dosing and its impact on the risk of SSI. Despite this, other guidelines suggest modifications of the antimicrobial dosing based on patient weight; there are neither RCTs nor systematic reviews that evaluate this question. 15 It is known that the achievement of therapeutic levels of cefazolin and cefepime are significantly delayed in the morbidly obese patients undergoing bariatric surgery. 97,98 Any antimicrobial agent used should also be dose- adjusted for renal function, when applicable.
14. Antimicrobial prophylaxis should be stopped after wound closure and case completion, even in the presence of a drain.
For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. 1,12,43
AP is not the use of antibiotics for treatment of a suspected infection; clinicians and surgeons may determine that the continuation of antibiotics is indicated where treatment, not prevention, of an infection is the goal of therapy.
While drain placement appears associated with a higher risk of SSI in most but not all studies, 99,100 none of these studies reported on urologic cases. Once placed, there is no high-level evidence that the continuation of antimicrobials throughout the period of wound drainage is protective. High-level evidence assessing SSI risks in the presence of a drain versus no drain with single dose AP is sorely needed.
Antimicrobials, similarly, are not indicated for the duration of indwelling catheterization in the postoperative period for the reduction of SSI 101 as they do not reduce the risk of a CAUTI.
15. Prior to any urologic procedure, the proceduralist or his/her team should inquire about urinary tract symptoms suggestive of a urinary tract infection.
Evaluation thereafter may also include a simple dipstick, laboratory performed microscopy, and/or formal culture, with assessed risks requiring higher levels of antimicrobial specificity and sensitivity.
While a urine dipstick positive for nitrites may be presumptive evidence of an infection as high bacterial colony counts will convert urinary nitrate to nitrite, the sensitivity of urinary nitrates is also poor, particularly where there is intense urinary frequency. Leukocyte esterase has poor positive predictive value due to chronic pyuria frequently seen in poorly emptying bladders or those on clean intermittent catheterization.
Urine microscopy is more sensitive: signs of skin contamination, such as presence of epithelial cells, suggest that a repeat instructed specimen or a catheterized specimen be obtained. Microscopy positive for pyuria and/or bacteriuria on a catheterized urine sample for microscopy or positive cultures >10 3 CFU/mL of common or expected uropathogens are highly predictive of infection but do not discriminate from colonization. Instrumentation in the setting of an infection is associated with an increased risk of post-procedural UTI/SSI, and these risks are further increased by patient and procedural characteristics. Positive microscopy findings should be confirmed with a culture for antimicrobial sensitivities in the perioperative setting where the risk of an SSI is high and targeted antimicrobial treatment may be required. Repeated urinalysis and cultures are not required in the low-risk patient if effective and appropriate symptom response has occurred.
16. If antimicrobial prophylaxis is to be considered prior to an operative procedure on the urinary tract, the urine should be tested and the results obtained and reviewed to properly inform selection of an antimicrobial agent.
Urine testing prior to a higher-risk procedure should include urine dipstick at a minimum, appreciating the test performance characteristics of this test, 102-104 or more accurately, urine microscopy. The results should be used to direct if further testing is warranted. If a patient is considered at risk for an infectious complication due to the patient’s risk factors (Table I), the associated SSI risk of the procedure (Table II), or the potential morbidity of a subsequent infection, results of the urine microscopy (proceeding to urine culture and sensitivity as indicated) should be obtained prior to the selection of the AP for the procedure, thereby allowing for assessment of the likely infectious organism and its potential virulence. Properly collected urine microscopy that does not reveal fungal forms appears adequate for screening for funguria and obviates the need for fungal cultures. Urine culture should not be performed without an accompanying urine microscopy due to common sample contamination as well as bacterial colonization. 105
In the surgical management of stones, a urine culture should be obtained if a UTI is suspected based on the urinalysis or clinical findings. If the culture demonstrates infection, the patient should be prescribed appropriate antibiotic therapy; 62 however, stone cultures are often discordant with urine cultures.
The indications for periprocedural AP coverage for asymptomatic colonization are dependent upon host-associated risks (Table I) and the procedural-associated risk probability of an SSI (Table II). If a urine culture in an appropriately collected specimen returns as positive in an asymptomatic individual, the significance of this colonization is variable (see Statement 18).
Urinary colonization commonly occurs in the elderly and in patients with urinary drainage maintained by intermittent catheterization. Colonization, as well as accompanying pyuria, is expected for those with long-term indwelling urinary catheters, or those who have had diversions or augmentative procedures involving bowel segments.
Procedures may be classified into low-, intermediate-, and high-risks, and as yet undetermined probability for an associated SSI, with a proposed procedural-associated risk probability for GU procedures is presented in Table II. As examples, a healthy patient undergoing a simple cystoscopy is at low risk and should not receive AP. Radical prostatectomy confers an intermediate risk, whereas the literature supports that transurethral prostate procedures confer a high risk of SSI without appropriate AP. This risk classification proposed herein is dependent on the likelihood of SSI, not the associated consequences of an SSI. For example, while the risk of SSI with implantation of prosthetic materials and devices is intermediate, the consequences of an SSI in this setting are high. The AP choices for urologic procedures are suggested by Table V based upon coverage for the likely current organisms and their associated sensitivities.
17. Elective procedures should be deferred in the presence of symptoms consistent with an active infection until an antimicrobial course is complete and associated symptoms have improved.
Culture results and sensitivities should dictate the antimicrobial agent in these settings. For example, should cultures demonstrate enterococci, specific agents active against enterococci, often amoxicillin or ampicillin, are required rather than empiric coverage for gram-negatives, most commonly in the form of a first-generation cephalosporin (a β-lactam), which do not adequately cover the high-prevalence of β-lactam-resistant enterococci.
If cephalosporin AP is appropriate but the patient is unable to tolerate β-lactams, vancomycin is an acceptable second-line alternative.
Consistent with standard practice for the treatment of UTIs, repeat urine microscopy after therapy is not necessary if associated symptoms have improved.
18. Asymptomatic bacteriuria and/or funguria may not require antimicrobial prophylaxis prior to a low-risk urologic surgical procedure in otherwise low-risk patients, with the exception of pregnant females, who DO require treatment of asymptomatic bacteriuria prior to an invasive urologic surgical procedure.
Historically, the identification of ASB normally occurring in 3-5% of women being associated with a 40% risk of pyelonephritis during their pregnancies lead to treatment of ASB in this cohort. 106 While controversial data exist, 107,108 pregnant patients with ASB are being treated with AP throughout pregnancy and delivery. 109,110 By extension, ASB was then widely treated in high-risk populations, the elderly, and the immunosuppressed. In non-urologic cases where entry into the GU system has not occurred, there is no benefit accrued to the treatment of ASB. Specifically, there is no benefit of treating ASB even in the setting of a total hip or knee prosthetic device placement. 111 Similarly, a urinalysis is not indicated in open heart surgical procedures. 112 Furthermore, there are risks of treating ASB. 110
However, single-dose treatment of ASB is recommended in pregnant females since they are a high-risk population. AP may be considered for other higher-risk individuals; Cameron et al. 24 carefully reviewed the literature regarding SSI after urodynamic studies (UDS), concluding that single-dose AP may not be warranted in individuals without risks factors. The factors that appeared to increase the SSI risk of UDS include known relevant GU anomalies, diabetics, prior GU surgery, a history of recurrent UTIs, post-menopausal women, recently hospitalized patients, patients with cardiac valvular disease, nutritional deficiencies, or obesity. The investigators suggested, with low levels of evidence, that there was an increased risk for patients with neurogenic lower urinary tract dysfunction, outlet obstruction or an elevated post-void residual volume, frailty, indwelling catheters, or on clean intermittent catheterization. Due to the low level of clinical evidence for many of these statements, more studies are needed to assess patient-associated risk for low–risk procedures.
Furthermore, ASB need not be managed any differently prior to intermediate- or higher-risk procedures as single-dose AP, the standard practice prior to GU procedures where a mucosal barrier will be broken, 113 is provided regardless of the presence of ASB. Parenthetically, renal transplant recipients have the lowest rate of SSIs among solid organ transplants with rates estimated between 3% and 11%. AP dosing of less than 24 hours of a first-generation cephalosporin is currently recommended for renal transplant; there is no prospective literature to suggest that ASB in renal transplant recipients should be treated according to a different regimen. A systemic review of the few studies of ASB available does not support the use of multiple doses of antimicrobials, 114 nor of repeated urinalysis to demonstrate clearing of ASB.
19. Asymptomatic bacteriuria and asymptomatic funguria do not require treatment prior to an elective surgical procedure not entering the genitourinary system.
ASB and asymptomatic funguria do not require periprocedural treatment for non-urologic or gynecologic cases; their treatment does not impact SSI or remote infections rates for the index procedure. 115
20. Urgent and semi-urgent urologic procedures required in the setting of an active urinary tract infection should have current urine microscopy available as well as microbiologic cultures with antimicrobial sensitivities prior to proceeding if the clinical presentation allows. Antimicrobial usage is not prophylactic in this setting and requires active assessment of the most probable organisms, their sensitivities, and the antimicrobial’s ability to penetrate the infected site.
Instrumentation of the GU tract in the setting of an active infection should be delayed, if possible and clinically appropriate, until the results of cultures and sensitivities are available. However, operative delay is often unsafe and places these patients at higher risk for periprocedural infectious complications.
21. Antimicrobial prophylaxis, when indicated, is to be accompanied by best surgical practices for surgical site infection reduction, and is never a substitute for these best practices.
Minimizing the risk of a SSI begins with creating an environment that minimizes the risk of introducing pathogens into the operative site. The Joint Commission has created standards to minimize SSI that should be followed in hospitals, surgical centers, and office-based settings. 74,116 Additionally, the Society for Healthcare Epidemiology of America/Infectious Diseases Society of America, 42 the CDC118 and the WHO 75,119 have recently updated the appropriate non-antimicrobial intraoperative and post-operative procedures recommended for SSI prevention.
As the patient's skin flora, gram-positive organisms and staphylococcal species in particular, is a major source of SSI procedures involving skin incision, patients should shower or bathe (full body) with soap (antimicrobial or non-antimicrobial) or an antiseptic agent on at least the night before the operative day. 1 RCT evidence suggests uncertain trade-offs between the benefits and harms regarding the optimal timing of the preoperative shower or bath, the total number of soap or antiseptic agent applications, or the use of chlorhexidine gluconate washcloths for the prevention of SSI. No recommendation has been provided by guidelines for these unresolved issues. 1
Mechanical bowel prep using oral antimicrobials is recommended prior to elective colorectal surgical procedures. The WHO considers a conditional (moderate) recommendation for mechanical bowel preparation and oral antimicrobials prior to colorectal procedures, 75 consistent with most urologic practices using colorectal segments. 22 Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated, as with mucous membranes of the genitalia of both genders. 1
Level I evidence recommends skin preparation with chlorhexidine and alcohol over betadine for non-mucosal surfaces. 120 The operative field is prepared by removing soil and eliminating transient bacteria. This is accomplished by scrubbing and/or painting with antiseptic solutions. Studies have compared various skin preparations with reports showing that 0.5% chlorhexidine in methylated spirits may be associated with lower rates of SSIs following clean surgery compared to alcohol-based povidone alone. 121,122 The specific solution chosen should be based upon availability, costs, and potential TEAE.
Intact sterile drapes placed around the prepared skin defines the procedural field and are broad enough in coverage to avoid contamination of the proceduralist or the instruments by touching non-sterile areas in the operating room. The use of plastic adhesive drapes with or without antimicrobial properties is not necessary for the prevention of SSI. While reducing contamination through either microperforations or frank perforations, double-gloving does not appear to confer a reduction in SSI, 123,124 although many surgeons continue this practice to reduce their own exposure. 125 Instruments should only be passed within the operative field in front of all surgeons and assistants. Both disposable and reusable equipment are checked ensuring that they are sterile and within expiration dates.
During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased inspired FiO2 to optimize local tissue oxygenation, and adequate volume replacement are also important adjuncts to SSI risk reduction. 118
In the operating room, surgeons are ultimately responsible for creating and maintaining the sterile microenvironment that incorporates the operative site and summarized herein. The first step is to create as clean an environment as possible. When applicable, the side of surgery is identified. The patient is the positioned and care is taken to make sure he or she is secured to the table with all pressure points padded. The extent of the operative field is determined by the surgeon based on the procedure being performed as well as anticipated emergencies that may require a larger sterile working area. Particularly in the setting of implanted prosthetic devices, it is important to limit traffic in the operating room.
Hair removal has been traditionally performed to better visualize the operative area and potentially decrease infection. Data to date do not show that hair removal prior to surgery decreases risk of infection. 126-128 If hair removal is performed, clipping hair 128 may be associated with lower infection compared with using razors.
Exposed hair of the operating room personnel is covered to avoid shedding into the wound, and a facemask is placed to minimize risk of disseminating airborne organisms. Personal protective eyewear should also be worn to protect the team from body fluids. Team members wash hands and arms up to the elbows. There are a variety of methods to accomplish this; however, there is no firm evidence that one type of hand antisepsis is better than another in reducing SSIs. 129 Alcohol rubs with additional antiseptic ingredients as well as chlorhexidine gluconate scrubs may reduce colony forming units compared with aqueous scrubs or povidone iodine hand scrubbing; however, this does not translate into a decrease in SSIs. Although longer scrub times may impact the incidence of SSIs, the data are weak. It is unclear whether nail picks and brushes have an impact on the number of colony forming units remaining on the skin.
Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. 1 While there is urologic literature to suggest a higher risk of infectious complications associated with a perioperative blood transfusion, 96 the benefit of appropriate transfusion protocols should prevail.
Antimicrobial agents (i.e., ointments, solutions, powders) need not be applied to the surgical incision for the prevention of SSI. 1 Antibiotic impregnated suture material appears to be useful in reduction of SSI 130-133 and cost reduction 134,135 across most but not all studies. 136 No recommendations in numerous SSI guidelines addressed stapled versus sutured closures, nor routine wound irrigation.
22. Antimicrobial prophylaxis is not recommended for routine cystoscopy or for urodynamic studies in healthy adults in the absence of infectious signs and symptoms.
For cystoscopy performed in patients without a concomitant urologic infection, no significant differences in post-cystoscopy UTIs were seen with or without AP 65,66 with moderate evidence allowing the establishment of a baseline rate of UTI of 3% in placebo-controlled cystoscopic trials. ASB is erroneously used in many other studies as an end-point; while bacteriuria can be persistent, the risk of development of a symptomatic UTI is poorly defined and varies with patient and procedural characteristics. Nonetheless, the associated risk of SSI when cystoscopy is performed in the setting of ASB is low. Cam et al. evaluated bacteriuria with rate of positive urine cultures after cystoscopy: the prevalence was 1% with AP, 2% with placebo. 117
Prophylactic antimicrobials are not indicated prior to UDS for patients without an associated UTI risk. UDS studies, however, are not frequently indicated in the otherwise asymptomatic healthy patient. Many studies are performed in more complicated clinical settings, on patients with higher risk of infections and serious complications from those infections. Individuals with neurogenic lower urinary tract dysfunction, those who are immunosuppressed (as in the transplant population), who gave known or suspected abnormalities of the urinary tract, with recent GU instrumentation and those who have undergone recent antimicrobial use are at an increased risk for UTI. 24 AP in these higher-risk settings would be trimethoprim-sulfamethoxazole. Alternatives include first- or second-generation cephalosporins, amoxicillin/clavulanate, or an aminoglycoside ± ampicillin. When indicated, a single oral dose given within an hour prior to the procedure, although dependent upon the agent’s oral pharmacokinetics, is sufficient and was the route chosen in nearly all reviewed studies.
23. Antimicrobial prophylaxis solely for the prevention of infectious endocarditis is not required for genitourinary procedures, even in the setting of a high-risk cardiac condition.
The most recent American College of Cardiology/American Heart Association guidelines concluded that the administration of antibiotics to prevent endocarditis is not beneficial for patients undergoing GU procedures. 137 This recommendation includes patients classified as having high-risk cardiac conditions such as prosthetic heart valve, history of infective endocarditis, or prior cardiac transplantation. However, there are rare circumstances when concomitant GU and oral mucosal procedures are performed (e.g. buccal graft urethroplasty) in which there may be a small benefit of standard dental AP to prevent endocarditis among high-risk cardiac patients.
24. Antimicrobial prophylaxis for the prevention of prosthetic hip or knee prostheses is recommended, particularly for genitourinary procedures at high risk of bacteremia, within two years of prosthetic joint placement and for high-risk populations.
Recent literature suggests that GU procedures do not represent a significant risk factor for subsequent prosthetic joint infections 138 even in the setting of ASB. 110 The historical literature is similarly weak on review, with a case report, 139 or non-GU related procedures. 140 However, due to the devastating harm associated with prosthetic joint infections, many orthopedic surgeons recommend AP with those GU procedures at higher risk of bacteremia, and in the higher-risk period during the first two years after prosthetic device implantation. 141 Those higher-risk procedures associated with transient bacteremia include transrectal prostate biopsy and the treatment of infected stones; patients with higher risk may be once again identified by consulting Table I. It should be noted that not all GU literature has found a statistically significant increase in SSI with patient frailty (mFI). 142
Periprosthetic joint infections grow predominantly non-GU organisms, with gram-positive cocci (GPC) in over 65%, and potential uropathogens in 20%. While there has been a progressive increase in infected artificial joint cultures growing Enterobacteriaceae, this is of unknown cause and has not been directly correlated with GU procedures. 143,144
The most recent statement by the American Academy of Orthopedic Surgeons (AAOS) in February 2009 Antibiotic Prophylaxis for Bacteremia in Patients with Joint Replacements asserts that “given the potential adverse outcomes and cost of treating an infected joint replacement, the AAOS recommends that clinicians consider antibiotic prophylaxis for all total joint replacement patients prior to any invasive procedure that may cause bacteremia.”
Surveillance systems for hospital-acquired infections do not record lower incident SSI, such as post-GU procedure associated periprosthetic joint infections, but rather are concerned with more common problems including CAUTI or infections with MDR organisms, as examples. 145
25. Antimicrobial prophylaxis may be considered at the time of clinical procedures such as trials of voiding, or removal of catheter or drain tubing, or stent or nephrostomy tube, especially when other patient and procedural risk factors are present.
RCTs from non-urologic procedures demonstrate no decrease in SSI with antimicrobials continued during the period of drain utilization. 146,147 Placement of a drain is associated with an increased risk of SSI, 99 but should be utilized when surgically appropriate. Drain placement itself may not be directly causative, as the increased risk of an SSI is likely associated with those cases necessitating a drain. Reduction of SSI may occur if drains are brought through a separate stab wound.
Historical studies suggest that AP at the time of catheter removal has been common urologic practice. 148 A recent systematic review suggested that patients indeed might benefit from AP at the time of catheter removal, as there was a significantly lower prevalence in symptomatic UTIs after AP given at the time of catheter removal. AP limited to the time of urinary catheter removal for general surgery, post-prostatectomy, and medical patients effectively reduced the incidence of symptomatic UTIs with a number needed to treat of 17. 149 The quality of the evidence was variable, with a high risk of selection and attrition bias in most studies reviewed. However, AP in high-risk patient populations should be considered, as shown in a small study of renal transplant recipients. 150
The recommendations to not continue antimicrobials during periods of catheter drainage and for surgical drains does not obviate the need for CAUTI-associated risk reduction protocols 151 and appropriate wound cares.
26. Noninvasive procedures such as shock wave lithotripsy do not require antimicrobial prophylaxis if the pre-procedural urine microscopy is negative for infection.
Based on the AUA Guideline on the Surgical Management of Stones, 62,63 AP should be administered prior to stone intervention for ureteroscopic stone removal, PCNL, open and laparoscopic/robotic stone surgery, using a single dose. AP agent choice is based on prior urine culture results and/or the local antibiogram.
27. Antifungal treatment, rather than single-dose prophylaxis, is recommended for patients with symptomatic fungal urinary tract infections at the time of exchange of any permanent drainage tube or stent once fungicidal levels are present.
Symptoms associated with the infection should have resolved prior to proceeding. Repeated cultures after a therapeutically successful course of therapy is not recommended unless the patient and procedure are high-risk.
28. Antifungal prophylaxis may not be necessary for those with asymptomatic funguria undergoing routine urinary catheter, nephrostomy or stent placement or exchange.
In the absence of neutropenia or other high-risk patient characteristics, nephrostomy exchanges and ureteral stenting procedures alone do not require antifungal prophylaxis for asymptomatic funguria. Of note, this Panel, therefore, is at variance with the IDSA recommendation of multiple doses of antifungal agents for this clinical scenario. 152 First, it is not common urologic practice to provide any antifungal coverage for routine stent exchange in the setting of asymptomatic funguria due to the understanding that these microscopy and culture findings are most consistent with colonization of a foreign body. 153,154 Second, there is a dearth of reports suggestive that this long-standing clinical protocol is risky, with no data available to suggest a high risk of fungal sepsis after drainage tube exchange procedures. Third, the IDSA cited evidence for a prolonged pre- and post-procedure treatment of asymptomatic funguria is of low quality and does not discriminate regarding the associated risks of specific GU procedures.
As is the case with ASB, for these routine low-risk Class II/clean-contaminated procedures, fungal colonization, including biofilms on foreign bodies, do not require antifungal prophylaxis.
29. Single-dose antifungal prophylaxis is recommended for patients with asymptomatic funguria undergoing endoscopic, robotic, or open surgery on the urinary tract.
The IDSA updated their Clinical Practice Guidelines for the Management of Candidiasis in 2016, and strongly recommended that patients with candiduria undergoing any urologic procedure be treated with either oral fluconazole or intravenous amphotericin B deoxycholate for several days before and after the procedure. 152 This BPS agrees that antifungal prophylaxis should be given to those patients undergoing specific intermediate- and high-risk GU procedures, these include resective, enucleative, or ablative outlet procedures; transurethral resection of bladder tumor; ureteroscopy; PCNL; all endoscopic procedures; procedures in which high pressure irrigants are used; and in those cases where surgical entry into the urinary tract is planned.
30. A longer course of periprocedural antifungal treatment is strongly recommended in neutropenic patients with funguria who have a urinary tract obstruction and are undergoing surgery on the genitourinary tract.
There are a limited number of indications to treat asymptomatic candiduria. This patient population is at high risk of fungemia, with a higher likelihood of morbidity and mortality if targeted antifungals are not used at the time of relief of obstruction. One such scenario that may lead to candidemia due to a urinary source occurs in neutropenic patients with a urinary tract obstruction, or in those who are undergoing urologic surgery. Antifungal treatment is generally recommended in these patients. 121, 122, 129, 155-157
31. Fungal cultures and sensitivities are recommended in patients who have fungus balls. Periprocedural antifungal treatment based on those sensitivities is strongly recommended at the time of treatment, or any subsequent treatments, of the fungus balls.
Patients undergoing treatment of fungal balls (mycetoma) require organism speciation with antifungal sensitivities, antifungal therapy at the time of the procedure, and continued antifungal treatment for an as yet undetermined length of therapy; the majority opinion is five to seven days. When indicated, oral fluconazole is preferred due to its convenience in oral formulation, excellent penetration into the upper and lower urinary tract, and good patient tolerance.
Speciation of fungal cultures is often not performed, in part, as funguria is very common in stented patients; however, there are cases where amphotericin B deoxycholate should be chosen. Such cases include patients infected with fluconazole-resistant Candida species or when there is a contraindication to using fluconazole (e.g., drug allergy, prolonged QTc, drug-drug interaction, acute liver injury). Candida krusei is almost always fluconazole resistant. Other species that have increased rates of fluconazole resistance or are susceptible but in a dose-dependent manner include C. glabrata, C. parapsilosis, C. tropicalis, and C. lusitaniae. As nephrotoxicity is common in patients receiving amphotericin beyond a single dose of prophylaxis, creatinine, potassium, and magnesium need to be closely monitored for those requiring repeated dosing.
The recommended dose of fluconazole is 400 mg (6 mg/kg) orally daily, and amphotericin B deoxycholate is 0.3–0.6 mg/kg intravenously daily. Dosage adjustment may be necessary in patients with renal impairment (decreased) or in Candida species that are susceptible to fluconazole in a dose-dependent manner (increased). The duration of treatment in the neutropenic individual or the patient with mycetoma cannot be specified given the lack of data to support the course duration. However, these high-risk patients or procedures on fungus balls would generally receive treatment five to seven days before and after the procedure. A shorter duration may be reasonable in cases of an immunocompetent host where the obstruction has been completely relieved. A longer course may be considered when there is the persistence of fungus balls, and/or if repeated procedures are necessary. In any case where prolonged antifungal treatment is considered, it would be prudent to consult with an infectious disease specialist for formal recommendations. In patients with nephrostomy tubes or stents, if clearance of candiduria is the goal, relief of the obstruction to allow removal of the nephrostomy tube or stent is preferred whenever possible to reduce the biofilm and recolonization of the urine. In cases where removal is not possible and the patient is symptomatic or obstructed, replacement to reduce biofilm is recommended. 152
As the risk of AP increases for the patient and his or her community, the benefits for many current AP practices remain understudied in high-quality RCTs. We laud the institutions and researchers now producing such comparative trials, which are rapidly appearing and changing the perceived need for and duration of AP. Many more of these trials are needed, specifically comparing single-dose AP for Class I skin incisions versus no antibiotics and comparing single-dose AP versus multiple-doses for higher-risk patients and procedures. Multiple questions remain unanswered, admittedly because of the low incidence of measurable events: registries would allow for risk calculation of orthopedic joint infection subsequent to GU procedures, and would appropriately assess blood cultures correlated with concurrent periprosthetic joint cultures, perhaps using advanced microbiologic techniques 158 to enhance source localization. Similarly, the multiple periprocedural interventions aimed at risk reduction for low- and moderate-risk procedures, including drain or catheter care and subsequent removal, could be compared with those same procedures without AP.
Class II wound classification requires further investigation into improved subclassifications by case-specific periprocedural risks; this would be inclusive not only of SSI and bacteremic events but of other periprocedural risks, such as hemorrhage with resumption of anticoagulants and antiplatelet therapy.
Surveillance data to more accurately define the at-risk populations and GU procedures are only possible when surgeons accurately record patient comorbidities, classify the wounds accurately, and report all SSI and bacteremic events to central repositories.
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|AAOS||American Academy of Orthopedic Surgeons|
|ACC/AHA||American College of Cardiology/ American Heart Association|
|AUS||Artificial genitourinary sphincter|
|BPH||Benign prostatic hyperplasia|
|BPS||Best Practice Statement|
|CAUTI||Catheter-associated urinary tract infection|
|CDC||Centers for Disease Control|
|DAEC||Diffusely adherent E. coli|
|Gen||Generation, as in first generation cephalosporin|
|GNR||Gram negative rod|
|GPC||Gram positive cocci|
|IPP||Implantable penile prosthesis|
|IDSA||Infectious Diseases Society of America|
|mFI||Modified frailty index|
|MIS||Minimally invasive surgery|
|MRSA||Methicillin-resistant Staphylococcus aureus|
|NNIS||National Nosocomial Infectious Surveillance|
|PG–SGA||Scored Patient-Generated Subjective Global Assessment|
|RCT||Randomized controlled trial|
|SCIP||Surgical Care Improvement Project|
|SSI||Surgical site infection|
|TEAE||Treatment-emergent adverse effects|
|TURP||Transurethral resection of the prostate|
|UPEC||Uropathogenic E. coli|
|UTI||Urinary tract infection|
|WHO||World Health Organization|