http://informahealthcare.com/jdt ISSN: 0954-6634 (print), 1471-1753 (electronic) J Dermatolog Treat, Early Online: 1–8 ! 2014 Informa UK Ltd. DOI: 10.3109/09546634.2014.906547

REVIEW ARTICLE

Topical antibiotic prophylaxis for prevention of surgical wound infections from dermatologic procedures: a systematic review and meta-analysis Michael Saco1, Nicole Howe2, Rajiv Nathoo3, and Basil Cherpelis2 J Dermatolog Treat Downloaded from informahealthcare.com by Nyu Medical Center on 05/25/15 For personal use only.

1

Morsani College of Medicine, University of South Florida, Tampa, FL, USA, 2Department of Dermatology & Cutaneous Surgery, University of South Florida, Tampa, FL, USA and 3Department of Dermatology, University of Florida, Gainesville, FL, USA

Abstract

Keywords

Importance: Topical antibiotics are not indicated for postsurgical wound infection prophylaxis in clean and clean-contaminated dermatologic surgeries, yet many dermatologists continue to prescribe them. The objective of our systematic review and meta-analysis was to critically assess the efficacy of topical antibiotics in terms of preventing postsurgical wound infections in the dermatology outpatient setting. Methods: PubMed, Embase, MD Consult, Science Direct, Springer Link, DynaMed and Cochrane online medical databases were searched from 1980 to 2013. Results: Using random effects modeling, the pooled odds ratio of developing a postsurgical wound infection was 0.71 (95% CI, 0.42–1.19). Discussion: Pooled data of the four trials in the meta-analysis did not show a statistically significant difference in incidence of postsurgical wound infections between topical antibiotics and petrolatum/paraffin. In the setting of moist occlusive dressings, there is no statistically significant difference in prophylactic efficacy between applying and not applying ointment to surgical wounds. Wounds at increased risk of developing surgical site infections include wounds in diabetics, wounds located in certain anatomic regions, and wounds created by some surgical procedures. Conclusions: Petrolatum should be used instead of topical antibiotics as a prophylactic measure to prevent postsurgical wound infections in the outpatient dermatologic setting.

Mohs surgery, petrolatum, postsurgical

Introduction Prophylactic antibiotics have remained a staple in wound management based on the principle that infection impairs the normal mechanism of wound healing (1,2). Topical antibiotics are frequently used for surgical wound infection prophylaxis, as this route of administration achieves high local drug concentrations without inducing significant systemic effects (3). Various dermatologic procedures performed in an office setting, ranging from skin biopsies to Mohs surgery, lead to the creation of a superficial skin wound, for which topical antibiotics are frequently prescribed to reduce risk of infection (4). Dermatologists prescribe more antibiotics to patients than physicians in any other medical specialty in USA. In 2003 alone, dermatologists wrote three to four million prescriptions for topical antibiotics (4–6). The perceived benefits of topical antibiotics stem not only from their antimicrobial effects, but also from the moist environment provided by antibacterial ointments (7–9). Although one of the primary causes of postsurgical wound infections is suboptimal skin antisepsis both preoperatively and postoperatively (10–12), the actual benefits of prophylactic topical antibiotics in

Correspondence: Michael Saco, Morsani College of Medicine, University of South Florida, 13330 Laurel Dr, Tampa, FL 33612, USA. E-mail: [email protected]

History Received 13 February 2014 Accepted 16 March 2014 Published online 7 April 2014

minimizing wound infections are not strikingly evident (13–18). The purpose of our systematic review and meta-analysis is to critically analyze the efficacy of topical antibiotics in preventing postsurgical wound infections in the dermatologic outpatient setting and then make clinical practice recommendations based on our findings.

Methods Our literature search was performed using the PubMed, Embase, MD Consult, Science Direct, Springer Link, DynaMed and Cochrane online medical databases from 1 January 1980 to 31 December 2013 to identify pertinent English-language scholarly journal articles. Figure 1 presents a flowchart detailing the literature search performed to obtain the articles used in our systematic review and meta-analysis. For each online database used, key search terms included dermatologic, surgery, or dermatology, surgical, in combination with the keywords wound, infection, prophylaxis, or prophylactic, topical, antibiotics. Three of the authors (M.S., N.H. and R.N.) independently reviewed the 578 titles and abstracts found during the initial literature search and narrowed them down to 119 full-text articles. The same three authors subsequently assessed the aforementioned 119 full-text articles in terms of eligibility for a systematic review and meta-analysis using predefined inclusion and exclusion

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Inclusion criteria for the current review included clinically relevant articles examining topical antibiotic prophylaxis for surgical wounds and surgical wound infection rates in dermatologic surgery, with more weight given to systematic reviews, meta-analyses and randomized-controlled trials, and less weight given to case reports and expert opinions. Exclusion criteria included articles that focused on surgical wound infection prophylaxis via antibiotics administered orally or parenterally rather than topically. Articles that primarily examined treatment of postoperative surgical wound infections instead of postsurgical wound infection prophylaxis were also excluded. Additionally, articles that included patients who underwent surgeries not normally performed in the dermatologic outpatient setting were excluded. Finally, studies that included contaminated or infected wounds in their study samples were excluded since wounds created secondary to dermatologic procedures are typically classified as either clean or clean-contaminated (19–21). Information regarding the different surgical wound classifications can be found in Table 1. Two of the authors (M.S. and N.H.) independently extracted data and performed a systematic review. The data recorded by each author included type of study and study sample, interventions or exposures, postsurgical wound infection rates and authors’ conclusions. The same two authors independently determined the quality of evidence for each study and then graded the strength of their clinical recommendations based on available data pertaining to benefits, risks, costs and/or biases. The quality of evidence for each study (A, B, C) and the grading of recommendations (1, 2A, 2B) were assigned based on the classification systems published in the Archives of Dermatology by Robinson et al. (24). Studies were designated as having high-, moderate- or low-quality evidence independently by the two authors (M.S. and N.H.) based on the aforementioned stratification system for evidence quality A, B or C, respectively. Final quality of evidence assessments and grading of recommendations were determined based on consensus between the two authors. We used a random effects model with inverse variance and DerSimonian and Laird weighting to calculate odds ratios in order to account for variability both between studies and within studies. Our model did not assume that the studies were homogeneous in study characteristics or patient population. Assessment of study heterogeneity was performed using the I2 statistic. All statistical analyses were performed via commercial software (Review Manager, version 5.2; The Cochrane Collaboration).

Results

Figure 1. Flowchart of study selection for systematic review and meta-analysis. PubMed, Embase, MD Consult, Science Direct, Springer Link, DynaMed and Cochrane online medical databases searched from 1 January 1980 to 31 December 2013. Inclusion criteria: topical antibiotic prophylaxis for surgical wounds and surgical wound infection rates in dermatologic surgery.

criteria. An article was included in the systematic review and/or meta-analysis if at least two of the three authors felt that it met our inclusion and exclusion criteria. Out of the 119 full-text articles analyzed, 15 were ultimately deemed eligible for our systematic review. Of these 15 studies, four randomized trials were selected for meta-analysis.

Table 2 provides an overview of the 4 randomized trials used in the meta-analysis examining the efficacy of topical antibiotics in postsurgical wound infection prophylaxis in the outpatient dermatologic setting. The quantitative results of this metaanalysis comparing topical antibiotics against petrolatum or paraffin in terms of postsurgical wound infection incidences as a measure of prophylactic efficacy are presented in Figure 2. Using random effects modeling, the pooled odds ratio of developing a postsurgical wound infection was 0.71 (95% CI, 0.42–1.19), indicating that there was no statistically significant difference in prevention of postsurgical wound infections between topical antibiotics and petrolatum/paraffin. Table 3 presents an overview of studies examining incidences of postoperative wound infections from dermatologic procedures in which no prophylactic topical antibiotics were prescribed.

Discussion Although use of topical antibiotics to prevent postsurgical wound infections in the dermatologic outpatient setting has decreased

Topical antibiotic prophylaxis

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Table 1. Classification of surgical wounds.

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Wound class (22)

Infection rate (21)

Description

Antibiotics (8)

Class I: Clean

Created on non-inflamed skin in a sterile surgical setting. Closed primarily unless closed drainage is required (19,21,22).

1–4%

Class II: Clean-contaminated

Occur as a result of entry into alimentary, respiratory or genitourinary tracts in which no evidence of infection is apparent and in a setting where no major break in sterile technique has occurred (20,21,23).

5–10%

Prophylaxis only in immunocompromised patients

Class III: Contaminated

Includes fresh, accidental, open wounds, as well as wounds created in settings where there are major breaks in sterile technique or gross spillage from alimentary tract. Also includes incisions made in areas with acute, nonpurulent inflammation (22).

6–25%

Therapeutic antibacterials indicated

Class IV: Infected/dirty

Includes old traumatic wounds contaminated with retained devitalized tissue, as well as purulent wounds and wounds containing foreign bodies. In these types of wounds, the causative organisms of postoperative infections were most likely present in operative field prior to surgery (12,22).

425%

Therapeutic antibacterials indicated

over the years, this practice should be eliminated completely (17). Since most wound infections occur as a result of contamination before wound closure, administering topical antibiotics postoperatively is not an effective measure to prevent postsurgical wound infections (34). The rates of postsurgical wound infection in the modern-day outpatient dermatologic setting are low, typically ranging from 0.7% to 4.0% (12–15,18,21,23,27, 28,31,32,35–38) even without prophylactic antibiotics secondary to current aseptic practices, such as preoperative surgical site preparation, sterilization of instruments and wearing gloves (4,22,39–41). Furthermore, most of the wound infections that develop in this setting are mild and easily treated, frequently with basic wound care management alone and no antibiotics (34). Based on high-quality level A evidence from a meta-analysis of four randomized trials (13–15,18), the recommended classification for using petrolatum instead of topical antibiotics in postsurgical wound infection prophylaxis in the setting of outpatient dermatologic procedures is grade 1. The results of the four randomized trials examining the efficacy of topical antibiotics in postsurgical wound prophylaxis (13–15,18) indicate that the key aspect of antibacterial ointments that is conducive to wound healing is most likely the moist environment provided by the ointment itself, rather than the bactericidal or bacteriostatic actions of the antibiotic. Moreover, the results of Dixon and colleagues’ randomized trial in which moist occlusive dressings were applied to all of the surgical wounds postoperatively demonstrated that the no ointment arm showed no statistically significant difference between the paraffin arm and the mupirocin arm. Therefore, adding additional moisture to the wound environment via paraffin or topical mupirocin is unnecessary when the surgical wound is covered with moist occlusive dressings (14). Additionally, a statistically significant increase in wound edge skin necrosis was observed in the mupirocin group, indicating that mupirocin ointment applied to postsurgical wounds covered by moist occlusive dressings may be of detriment to patients. The recommended classification for not using ointment on wounds with moist occlusive dressings for prevention of infection in postoperative wounds created by dermatologic surgeries in an outpatient environment is grade 1, based on high-quality level A evidence from one randomized trial (14).

Prophylaxis not indicated

The increased costs and adverse events associated with topical antibiotics are two other reasons to use petrolatum instead of topical antibiotics to prevent postsurgical wound infections (18). Topical antibiotics have been recognized as increasingly common causes of allergic contact dermatitis in USA, with neomycin being reported as the third most common contact allergen in the general patch test population of North America (17). A large study in which 3120 patients underwent patch testing demonstrated that neomycin caused an allergic reaction in 11.6% of patients, and bacitracin caused an allergic response in 9.1% of patients (42). Additionally, multiple case reports implicating bacitracin as the etiologic agent of anaphylactic reactions in certain patients have been published (43–46). Continued use of topical antibiotics in practice by a considerable number of dermatologists has contributed to the already steadily increasing rates of antibiotic resistance (17). Reports of resistance in multiple different species of bacteria to commonly prescribed antibiotics have been reported, including Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Streptococcus pneumoniae and Propionibacterium acnes (37,47). In order to conserve the efficacy of the antibiotics currently available, dermatologists should be more judicious with their prescription habits. Antibiotics should be reserved for cases that meet both of the following criteria: the wound carries a higher-than-normal risk of developing an infection, and the prophylactic antibiotic will reduce the patient’s risk of developing an infection to a degree that is both statistically and clinically significant (48). Based on the results of the meta-analysis, topical antibiotics and petrolatum are equally efficacious in preventing postsurgical wound infections. Accordingly, even in wounds that are at an increased risk of developing an infection, petrolatum should be used for postsurgical wound infection prophylaxis instead of topical antibiotics. Wounds located below the knees or in the groin region are associated with higher rates of surgical site infections, as are basal cell carcinoma and squamous cell carcinoma excisions, skin grafts, flaps on the nose or ear and wedge resections on the ear or lip (8,13,17,21,23,27–33,49). Based on low-quality level C evidence from multiple large-scale case series (Table 3), the recommended classification for oral antibiotic prophylaxis against postsurgical infection of wounds created in these scenarios is

Type of study and study sample

–Prospective, randomized, nonblinded trial –147 auricular wounds left to heal by secondary intent from 142 Mohs surgery patients

–Prospective, blinded, randomized-controlled trial –1801 surgical wounds from skin lesion excisions in 778 patients

–Prospective, randomized, double-blind, placebo-controlled trial –973 wounds from 972 patients undergoing minor dermatologic surgeries

–Randomized, double-blind, prospective trial –1249 surgical wounds from 922 patients undergoing dermatologic procedures at outpatient dermatology clinics

Source

Campbell et al. (13)

Dixon et al. (14)

Heal et al. (15)

Smack et al. (18)

A

A

A

A

Compared to gentamicin ointment, petrolatum is equally efficacious in surgical wound prophylaxis and may be less irritating.

Application of ointment to surgical wounds prior to placement of moist occlusive dressings does not benefit patients. Usage of mupirocin ointment on clean surgical wounds is not indicated, especially in light of risk of promoting antibiotic resistance. The benefit observed with topical chloramphenicol was statistically, but not clinically significant; physicians should not increase usage of topical antibiotics for surgical wound prophylaxis. White petrolatum is a safe and equally efficacious alternative to bacitracin ointment for surgical wound prophylaxis in the ambulatory surgery setting.

No statistically significant differences in wound discomfort, aesthetic outcome, healing time, patient satisfaction or pain level. Higher incidence of wound edge skin necrosis in mupirocin group was statistically significant (p ¼ 0.007) Absolute reduction in infection rate was only 4.4% with topical chloramphenicol

Difference between the two groups in wound healing time was not statistically significant

1.4% in no ointment group, 1.6% in paraffin group and 2.3% in mupirocin group; differences not statistically significant

6.6% in chloramphenicol group and 11.0% in control group; difference was statistically significant (p ¼ 0.01)

2.0% in white petrolatum group and 0.9% in bacitracin group; difference not statistically significant

Patients randomized to one of three groups prior to placement of moist occlusive dressings: 1. no ointment, 2. paraffin ointment 3. mupirocin ointment

Patients received a single topical dose of either chloramphenicol or paraffin ointment

Group 1: bacitracin ointment under occlusive wound dressings Group 2: white petrolatum under occlusive wound dressings

Quality of evidence

11.90% of gentamicin group and 3.33% of petrolatum group developed inflammatory chondritis; study not sufficiently powered to determine if difference was statistically significant

Authors’ conclusions

Other noteworthy findings

Incidence of postoperative suppurative chondritis was 4.76% in gentamicin group and 6.67% in petrolatum group; difference not statistically significant

Postsurgical wound infection rates

Group 1: gentamicin ointment Group 2: petrolatum

Interventions or exposures

Table 2. Efficacy of topical antibiotics in postsurgical wound infection prophylaxis.

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Figure 2. Random effects meta-analysis of postsurgical wound infection incidence with topical antibiotics versus petrolatum/paraffin. IV, inverse variance; middle vertical line, line of no difference; squares with horizontal lines, odds ratios with 95% CIs; diamond, pooled analysis of overall 95% CI of effect estimate of topical antibiotics and petrolatum/paraffin on postsurgical wound infection incidence.

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Table 3. Postoperative wound infection rates from outpatient dermatologic procedures.

Source

Type of study and study sample

Interventions or exposures

Postsurgical wound infection rates

Authors’ conclusions

Quality of evidence

Dixon et al. (25)

4.2% diabetics, 2.0% non–Prospective cohort study Prophylactic antibiotics diabetics; statistically given if had recent joint –551 surgeries in 196 diasignificant difference prosthetic surgery, had betics; 6673 surgeries in (p50.001) surgery below knee in 4001 non-diabetics last 2 years of study, or at high endocarditis risk

Diabetic patients experience more postoperative skin infections than nondiabetic patients. Antibiotic prophylaxis may be indicated in diabetic patients undergoing high-risk skin surgeries.

B

Dixon et al. (26)

–Prospective cohort study Patients received no instructions regarding –646 surgeries in 439 smosmoking kers; 6578 surgeries in 3758 non-smokers

1.9% smokers, 2.2% nonsmokers; difference not statistically significant

Smokers and non-smokers experience similar postsurgical wound infection rates.

B

Amici et al. (27)

–Prospective case series –3788 outpatient dermatologic surgeries

Prophylactic antibiotics were prescribed for 79 surgeries (reasons for majority of cases not documented); prophylactic antibiotics not prescribed for the other 3709 surgeries

Outpatient dermatologic –Overall: 1.9% surgeries are associated Two independent risk facwith a low postoperative tors for postoperative infection rate. wound infections were Prophylactic antibiotics anesthetic complications are unnecessary in most (p ¼ 0.004) and hemorcases, but may be indirhagic complications cated in higher risk (p ¼ 0.001) surgeries.

C

Dixon et al. (28)

–Prospective case series –5091 dermatologic surgeries, 2424 patients

No patients received prophylactic antibiotics

–Overall: 1.47% –Skin grafts: 8.70% (p50.001) –Wedge excision: 8.57% (p50.001) –Skin flap repairs: 2.94% (p50.001) –Sites below knee: 6.92% (p50.001) –Groin: 10% (p ¼ 0.03) –Increased incidence of wound infections in wedge resections of ear or lip

Prophylactic antibiotics after dermatologic surgery may be warranted in all procedures below knee or involving groin, all skin grafts, and wedge excisions of lip and ear. Prophylactic antibiotics not indicated for skin flaps.

C

Futoryan and Grande (23)

–Case series –1047 surgeries (517 excisions, 530 Mohs procedures)

Some patients received antibiotics preoperatively (number not reported)

–Overall: 2.29% –Higher rates of wound infection in surgeries involving ear and involving large postoperative defects

Dermatologic surgery can be performed safely in office-based settings. Large postoperative defects and lesions involving ear may be associated with increased incidence of postoperative wound infections.

C

(continued )

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Table 3. Continued

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Source

Type of study and study sample

Interventions or exposures

Postsurgical wound infection rates

Authors’ conclusions

Quality of evidence

Heal et al. (29)

No patients received –Prospective case series prophylactic antibiotics –857 patients with minor skin excisions performed anywhere except face

High-risk surgeries (basal –Overall: 8.6% or squamous cell carcin–Lower legs and feet: 15% oma excisions and (p ¼ 0.009) lesions made at or below –Thighs: 14.0% (p ¼ 0.005) thigh) warrant antibiotic –Squamous cell carcinoma prophylaxis. excision: 13.5% (p ¼ 0.002) –Basal cell carcinoma excision: 11.4% (p ¼ 0.006)

C

Heal et al. (30)

–Prospective case series –972 minor skin excisions, 972 patients

No patients received prophylactic antibiotics

High-risk surgeries (lesions –Overall: 8.7% on upper extremities, –Legs and feet: 18.8% lesions at or below thigh, (p50.001) basal or squamous cell –Thighs: 16.2% (p50.001) carcinoma excisions and –Upper extremities: 12.9% larger excisions) warrant (p50.001) antibiotic prophylaxis. –Squamous cell carcinoma excision: 18.7% (p ¼ 0.001) –Basal cell carcinoma excision: 10.1% (p ¼ 0.001) –Length of Excision: 3.4%16.7% (p50.001)

C

Maragh and Brown (31)

None of the patients –Prospective case series received prophylactic –1115 surgical incisions antibiotics; patients were from 1000 patients examined at 1 week and undergoing Mohs sur4 weeks postoperatively gery under clean surgical for signs of infection at conditions in an outsite of surgical incision patient setting

–Overall: 0.7% –Nose: 1.7% –Flap closures 2.4% –Multistaged procedures: 0.8%

Using topical antibiotics for postoperative wound infection prophylaxis in Mohs surgery is not appropriate. Surgeries with risk factors for postsurgical wound infections may warrant antibiotic prophylaxis.

C

Rogers et al. (21)

–No patients received top–Prospective case series ical antibiotics for –1204 Mohs surgical inciprophylaxis against sursions under clean surgigical wound infections cal conditions from 1000 patients

–Overall: 0.91% –Flap closures: 2.67%

Mohs surgery can be safely performed in an outpatient setting without having to prescribe antibiotics for prophylaxis against postoperative wound infections.

C

Rogues et al. (32) –Prospective case series –3491 dermatologic surgeries

Some patients received antibiotics preoperatively (number not reported)

Increased infection rates –Overall: 1.9% observed in surgeries –Nose: 2.8% involving nose and exci–Excision with reconstructsions with reconstructive ive procedure: 4.3% procedures may warrant (statistically significant antibiotic prophylaxis in increased infection rates these scenarios. with immunosuppressants, males and not wearing sterile gloves) –Excision only: 1.6%

C

Sylaidis et al. (33) –Prospective case series –464 clean wounds, 351 patients

Facial plastic surgery

Facial surgeries associated –Nasal area: 6.5% with high-risk factors, –Auricular area: 5% such as surgery in nasal –Rest of face: 1.5% or auricular areas, skin –Up to 15-fold increase in cancer excisions, skin postoperative infection grafts and local flaps rate seen in skin cancer may warrant antibiotic surgeries, skin grafts and prophylaxis. local flaps

C

grade 2B. The recommended classification for prescribing oral antibiotics to diabetics undergoing high-risk outpatient dermatologic surgeries to prevent postoperative wound infections is grade 2A, based on moderate-quality level B evidence from one prospective cohort study that diabetics are at an increased risk of developing postsurgical wound infections when compared to

non-diabetics (25). Also based on moderate-quality level B evidence from one prospective cohort study (26), the recommended classification for not prescribing antibiotics to smokers at normal risk of developing infection as a prophylactic measure to prevent postsurgical wound infections from outpatient dermatologic procedures is grade 2A.

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DOI: 10.3109/09546634.2014.906547

This study had several strengths. For our initial literature search, we utilized several online medical databases reviewing articles covering over 30 years of research to carefully select articles that seemed pertinent to our investigation. In our systematic review, three authors independently selected articles for systematic review and meta-analysis based on predefined inclusion and exclusion criteria. Two authors then independently performed a systematic review of 15 full-text articles and a metaanalysis of four randomized trials in which quality of evidence and grading of recommendations were independently assigned, with final determinations based on consensus between the two authors. The study also had several weaknesses. For the meta-analysis, each of the four randomized trials compared a different antibiotic with petrolatum/paraffin. Even though this aspect of our study allowed for critical assessment of the efficacy of four different topical antibiotics instead of just one, having data from multiple randomized trials assessing the efficacy of the same topical antibiotic would have resulted in more reliable data pertaining to one specific topical antibiotic. Moreover, our recommendation against using prophylactic topical antibiotics is a general statement applying to all topical antibiotics even though data pertaining to only four different topical antibiotics were analyzed in our study. Even though there are a wide variety of topical antibiotics available, it would not be feasible to perform trials assessing the prophylactic efficacy of every single topical antibiotic. Additionally, there were no randomized trials available to examine risk factors associated with increased incidence of developing postsurgical wound infections. With the exception of the prospective cohort studies examining incidence of wound infections in diabetics and smokers compared to controls, determination of risk factors for developing postsurgical wound infections was based on large-scale case series in which there was some between-study variability in terms of whether or not certain anatomic locations or types of surgeries were associated with statistically significant increases in incidence of postoperative wound infection. Future studies should attempt to identify clearer indications for oral antibiotic prophylaxis for outpatient dermatologic surgeries.

Conclusions In conclusion, based on our systematic review and meta-analysis, petrolatum should be used instead of topical antibiotics as a prophylactic measure to prevent postsurgical wound infections from outpatient dermatologic procedures. Ointment does not need to be applied to surgical wounds for infection prophylaxis if they are covered by moist occlusive dressings. For some patient populations and surgical procedures associated with an increased risk of wound infection development, prophylactic oral antibiotics may be indicated.

Declaration of interest The authors report no conflicts of interest.

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Topical antibiotic prophylaxis for prevention of surgical wound infections from dermatologic procedures: a systematic review and meta-analysis.

Topical antibiotics are not indicated for postsurgical wound infection prophylaxis in clean and clean-contaminated dermatologic surgeries, yet many de...
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