Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Primary: * To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision * To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Must be 18 years of age

• Has histologically confirmed non-malignant vulvar pathology

• Is scheduled or planning for WLE/SPV

• Signed informed consent obtained prior to any protocol specific procedures

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Amanda Urban
AJR5Y@uvahealth.org
434.409.3100
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 91
Treatments
Experimental: Positive Perioperative Vaginitis
Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov