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

Phase 2

Completed

• Conditions: Premalignant Vulvar Lesion; Benign Vulvar Lesion
• Interventions: Drug: Cefazolin

• Registration Number: NCT03578965
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Study Start: 2018-07-13
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2022-10
• Results First Submitted: 2022-10-26
• Results First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Results First Posted: 2022-11-21
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Antibiotic prophylaxis prior to skin incision	Cefazolin	-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.

Primary Outcome Measures

Name	Time	Method
Vulvar Wound Complications Compared Between the Two Arms	Within 30 days of surgery (estimated to be 30 days)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection	Within 30 days of surgery (estimated to be 30 days)	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.
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications	Within 30 days of surgery (estimated to be 30 days)	* 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
Incidence of Adverse Events to Antibiotic Use	Within 30 days of surgery (estimated to be 30 days)	-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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States