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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaginitis, Vulvar Diseases

Intervention / Treatment
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* Diagnostic Test: vaginitis panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: vaginitis panel|vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 8 weeks |