Actively Recruiting
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Led by University of Virginia · Updated on 2025-10-20
91
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Unable to give informed consent
- Women who are pregnant or nursing (lactating) women at time of consent
- No prior RT
- No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
- No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
- Not immunosuppressed or compromised
- No active HIV (must have undetectable viral load)
- Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
- No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
- Uncontrolled diabetes mellitus
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Amanda Urban
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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