RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-25
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06070454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be 18 years of age
  2. * Has histologically confirmed non-malignant vulvar pathology
  3. * Is scheduled or planning for WLE/SPV
  4. * Signed informed consent obtained prior to any protocol specific procedures
  1. * Unable to give informed consent
  2. * Women who are pregnant or nursing (lactating) women at time of consent
  3. * No prior RT
  4. * No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
  5. * No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
  6. * Not immunosuppressed or compromised
  7. * No active HIV (must have undetectable viral load)
  8. * Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
  9. * No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
  10. * Uncontrolled diabetes mellitus

Contacts and Locations

Study Contact

Amanda Urban
CONTACT
434.409.3100
AJR5Y@uvahealth.org

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2026-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Vaginitis
  • Vulvar Diseases