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NCT Number: NCT06070454

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location status: Recruiting

Location contact

Amanda Urban, MS

CONTACT

[email protected]

434-409-3100

Carrie Sopata, MD

CONTACT

[email protected]

Carrie Sopata, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginitis panel

Diagnostic Test

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

Primary outcomes

  1. the rate of perioperative vulvovaginitis

    Time frame: 8 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

  2. rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown

    Time frame: 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Urban

CONTACT

[email protected]

434.409.3100

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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