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Study on Infectious Vulvovaginitis and Wound Complications After Vulvar Surgery

This study is looking at how common infectious vulvovaginitis (an infection of the vulva and vagina) is in women who are having surgery to remove non-cancerous vulvar lesions. Researchers want to see if having vulvovaginitis around the time of surgery is linked to problems with wound healing, such as cellulitis (a skin infection) or the incision breaking open. To do this, you would have a vulvovaginal swab taken on the day of surgery to test for common infections like bacterial vaginosis (BV), trichomonas, and candida. The study aims to enroll 91 women who are at least 18 years old, have a confirmed non-cancerous vulvar condition, and are scheduled for vulvar surgery. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 91 participants. It is designed to evaluate the rate of perioperative vulvovaginitis and its correlation with wound complications.
What's involved
You would have a vulvovaginal swab taken on the day of surgery. Your progress would be checked with a phone call one week after surgery and a physical exam 4-6 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks to measure the rate of perioperative vulvovaginitis and wound complications.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06070454

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

Recruiting
NAAges 18+InterventionalScreening
University of Virginia
~91 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Vaginitis panel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
the rate of perioperative vulvovaginitis
Measured over 8 weeks
+1 more outcome measured

Conditions

Vaginitis
Vulvar Diseases

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NCT06070454

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Amanda Urban
[email protected]
434.409.3100
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • the rate of perioperative vulvovaginitis8 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 breakdown8 weeks

    To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease