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

Who can join

Ages 18 and older · Women

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Vaginitis panel (diagnostic test)

Sponsor: University of Virginia · Participants: 91 · Started: Apr 25, 2024

Contact the study team

• Amanda Urban · Phone: 434.409.3100

Official record on ClinicalTrials.gov — NCT06070454

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.