Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT06070454

Conditions

Vaginitis

Vulvar Diseases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vaginitis panel

Study Details

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.

Conditions

Vaginitis

Vulvar Diseases

Study ID

NCT06070454

Start date

Apr 25, 2024

Status verified date

Oct, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

91 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Positive Perioperative Vaginitis

Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Interventions

Vaginitis panel

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

Primary outcome measure

  • the rate of perioperative vulvovaginitis [ Time Frame: 8 weeks ]
  • rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Amanda Urban

434.409.3100AJR5Y@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Amanda Urban, MS

434-409-3100ajr5y@virginia.edu

Carrie Sopata, MD

ces9cz@uvahealth.org

Principal Investigator:

Carrie Sopata, MD

More Information

Sponsor

University of Virginia

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-10-20.