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

Not Applicable

Not yet recruiting

• Conditions: Vaginitis; Vulvar Diseases
• Interventions: Diagnostic Test: Vaginitis panel

• Registration Number: NCT06070454
• Lead Sponsor: University of Virginia

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 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Study Start: 2023-11-14
• Primary Completion: 2025-11-14
• Study Completion: 2025-11-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive Perioperative Vaginitis	Vaginitis panel	Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Primary Outcome Measures

Name	Time	Method
the rate of perioperative vulvovaginitis	8 weeks	To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown	8 weeks	To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States