Clinical trial NCT06070454: Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Official title: Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginitis
Vulvar Diseases
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: the rate of perioperative vulvovaginitis
timeFrame: 8 weeks
measure: rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: