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

University of Virginia91 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Vaginitis

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the rate of perioperative vulvovaginitis

To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision

Time frame: 8 weeks

rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown

To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease