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NCT06070454NARecruiting

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

University of Virginia

Start Date

4/25/2024

Completion Date

8/1/2026

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.

Detailed Description

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Vaginitis panel

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Conditions

VaginitisVulvar Diseases

Locations

University of Virginia

Charlottesville, Virginia 22908

United States