NCT06070454

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Aug 2026

First Submitted

Initial submission to the registry

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 25, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

September 29, 2023

Last Update Submit

October 16, 2025

Conditions

VaginitisVulvar Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Positive Perioperative Vaginitis

EXPERIMENTAL

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

Diagnostic Test: Vaginitis panel

Interventions

Vaginitis panelDIAGNOSTIC_TEST

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

Positive Perioperative Vaginitis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

VaginitisVulvar Diseases

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Amanda Urban

CONTACT

434.409.3100AJR5Y@uvahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

April 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)