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

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

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.

Study Overview

• Status: Completed
• Conditions: Premalignant Vulvar Lesion; Benign Vulvar Lesion
• Intervention / Treatment: Drug: Cefazolin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Mary M Mullen, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2018
• Primary Completion (ACTUAL): November 23, 2021
• Study Completion (ACTUAL): November 23, 2021

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: 201804136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No