Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

Study Overview
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Brief Summary
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A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

Official Title
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Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial

Conditions
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Premalignant Vulvar Lesion, Benign Vulvar Lesion

Intervention / Treatment
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* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women, >=18 undergoing vulvar surgery Biopsy proven benign or premalignant lesion requiring surgical management. Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Women who are pregnant Women scheduled to undergo a radical vulvectomy Women scheduled to undergo a concomitant graft, flap or plastic surgery Women <18 years of age History of prior vulvar radiation Inability to sign an informed consent form prior to registration on study Inability to understand spoken or written English Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A: No antibiotic prophylaxis prior to skin incision<br>-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. | |
| Experimental: Arm B: Antibiotic prophylaxis prior to skin incision<br>-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. | Drug: Cefazolin<br>* -If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vulvar Wound Complications Compared Between the Two Arms | Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection. | Within 30 days of surgery (estimated to be 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications. | Within 30 days of surgery (estimated to be 30 days) | 
| Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery. The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures | Within 30 days of surgery (estimated to be 30 days) | 
| Incidence of Adverse Events to Antibiotic Use | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | Within 30 days of surgery (estimated to be 30 days) |