Phase 2
N=50
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
Premalignant Vulvar Lesion · Benign Vulvar Lesion
Bottom Line
View on ClinicalTrials.gov: NCT03578965 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Vulvar Wound Complications Compared Between the Two Arms — 6; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cefazolin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vulvar Wound Complications Compared Between the Two Arms |
6; 10 | — |
| SECONDARY Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications |
5; 8; 16; 8; 1; 2 | — |
| SECONDARY Incidence of Adverse Events to Antibiotic Use |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03578965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.