Status:
RECRUITING
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Lead Sponsor:
University of Virginia
Conditions:
Vaginitis
Vulvar Diseases
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 vul...
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 vul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06070454
Start Date
April 25 2024
End Date
August 1 2026
Last Update
October 20 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908