Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
NCT ID: NCT06070454
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
91 participants
INTERVENTIONAL
2024-04-25
2026-08-01
Brief Summary
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* 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.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Positive Perioperative Vaginitis
Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.
Vaginitis panel
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida
Interventions
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Vaginitis panel
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Carrie Sopata
Associate Professor
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSR230407
Identifier Type: -
Identifier Source: org_study_id
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