Evaluating vulvovaginitis effects on surgical outcomes after vulvar excision
Official title: Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Run by University of Virginia · NCT06070454 · Data updated 2026-11-12
This study is testing how common vulvovaginitis is in women having surgery for non-cancerous vulvar conditions and whether it affects their recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 91 (estimated) |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charlottesville, Virginia) |
| Status | Recruiting |
| Started | April 25, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | October 20, 2025 |
| Trial ID | NCT06070454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with histologically confirmed non-malignant vulvar pathology scheduled for surgical excision.
✕Probably not a fit
Patients who are pregnant, immunosuppressed, or have a history of recent antibiotic use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the rate of perioperative vulvovaginitis in patients with non-malignant vulvar disease undergoing surgical excision. It will involve collecting vulvovaginal swabs preoperatively to test for common causes of vulvovaginitis, including bacterial vaginosis, trichomonas, and candida. The correlation between the incidence of vulvovaginitis and postoperative complications such as wound cellulitis and incisional breakdown will be evaluated through follow-up phone calls and physical exams. The study is conducted at the University of Virginia in central Virginia.
Why it matters
Potential benefit: If successful, this study could lead to improved management of vulvovaginitis and reduced postoperative complications for patients undergoing vulvar surgery.
How similar studies have gone: While the specific approach of this study may be novel, similar studies have shown that addressing vulvovaginitis can impact surgical outcomes positively.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Virginia
Charlottesville, Virginia, United States Recruiting
Study contacts
- Study coordinator: Amanda Urban
- Email: AJR5Y@uvahealth.org
- Phone: 434.409.3100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.