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

Recruiting now · Not applicable

Conditions studied: Vaginitis, Vulvar Diseases

In brief

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.

Key facts

Study ID

NCT06070454

Run by

University of Virginia

People needed

91

Starts

2024-04-25

Expected to finish

2026-08-01

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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