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

Launched by UNIVERSITY OF VIRGINIA · Sep 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how often women develop a condition called vulvovaginitis, which is an infection in the vulvar area, after having surgery to remove non-cancerous growths. The study will involve testing for common causes of vulvovaginitis, such as bacterial infections and yeast infections, using a simple swab taken on the day of surgery. The researchers want to see if there is a link between having vulvovaginitis and complications with surgical wounds, like infections or breakdowns, in the weeks following the operation.

To be eligible for this trial, women must be at least 18 years old and have a confirmed diagnosis of a non-cancerous vulvar condition that requires surgery. They should not be pregnant, nursing, or have had certain recent medical treatments that could affect the results. Participants can expect to have a follow-up phone call one week after surgery and a physical exam about four to six weeks later to check on their recovery. This trial is currently recruiting participants, and it aims to help improve understanding of how infections may impact healing after surgery in women with vulvar diseases.

Gender

FEMALE

Eligibility 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