Vaginitis, Vulvar Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTVaginitis panel
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAmanda Urban
Outcome results
None listed