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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06070454
Status
Recruiting
Apply to this trial

Conditions

  • Vaginitis
  • Vulvar Diseases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vaginitis panel — DIAGNOSTIC_TEST
    vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida

Study Details

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.

Key Dates

Start date
Apr 25, 2024
Status verified
Oct 2025
Primary completion
Jun 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Positive Perioperative Vaginitis
    Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Primary Outcome Measure

the rate of perioperative vulvovaginitis [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Amanda Urban, MS
[email protected]
434-409-3100
Carrie Sopata, MD
[email protected]
Carrie Sopata, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By research site
University of Virginia· Charlottesville, VA

Related Studies