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

University of Virginia

Status: Enrolling

Conditions: Vulvar Diseases; Vaginitis

Treatments: Diagnostic Test: Vaginitis panel

Study type: Interventional

Funder types: Other

Identifiers

NCT06070454

HSR230407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Positive Perioperative Vaginitis

Experimental group

Description:

Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Treatment:

Diagnostic Test: Vaginitis panel

Sponsor of this trial

Lead Sponsor

University of Virginia