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

Vaginitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070454
• Other study ID #: HSR230407
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: November 14, 2025

Study information

• Verified date: September 2023
• Source: University of Virginia
• Contact: Rachel Lacy
• Phone: 4342430126
• Email: rmc9p[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 91
• Est. completion date: November 14, 2025
• Est. primary completion date: November 14, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Precancerous Conditions
• Vaginitis
• Vulvar Diseases
• Vulvovaginitis

Intervention

Diagnostic Test:
• vaginitis panel
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of perioperative vulvovaginitis	To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision	8 weeks
Primary	rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown	To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease	8 weeks