Actively Recruiting
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Led by University of Virginia · Updated on 2025-10-20
91
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to measure how often perioperative vulvovaginitis occurs in patients with non-cancerous vulvar disease who need surgical removal of affected tissue. It also examines how vulvovaginitis relates to complications like wound cellulitis and incisional breakdown in these patients undergoing surgical procedures such as simple partial vulvectomy or wide local excision. The study uses a vulvovaginal swab to detect common infections including bacterial vaginosis, trichomonas, and candida on the day of surgery. Participants will have a vulvovaginal swab collected preoperatively to test for infections causing vulvovaginitis. Those testing positive for bacterial vaginosis, candida, or trichomonas form the experimental group. The study involves no drug treatments but focuses on diagnostic testing and monitoring outcomes related to wound healing after vulvar excision. The primary evaluation period extends up to 8 weeks following surgery. During the study, participants will be contacted by phone one week after surgery to assess for vulvovaginitis and wound complications. They will also have a physical exam between 4 to 6 weeks postoperatively to check for wound cellulitis or breakdown. Researchers will measure the rates of these infections and complications to understand their relationship. The total study duration per participant includes the surgical visit and follow-up assessments up to 8 weeks after the procedure.
CONDITIONS
Brief Title
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age
- Has histologically confirmed non-malignant vulvar pathology
- Is scheduled or planning for wide local excision or simple partial vulvectomy
- Signed informed consent obtained prior to any protocol specific procedures
You will not qualify if you...
- Unable to give informed consent
- Women who are pregnant or nursing (lactating) women at time of consent
- Recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
- History of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
- Immunosuppressed or compromised
- Active HIV infection (must have undetectable viral load)
- Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis (inhaled corticosteroids allowed)
- Active uncontrolled severe infections not responding to antibiotics, except acute or chronic pelvic inflammatory disease
- Uncontrolled diabetes mellitus
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery
Participants undergo a vulvovaginal swab test to check for common causes of vulvovaginitis before their surgery.
1 visit (in-person)
Duration - Day of surgery to 1 week post-surgery
Participants undergo surgical excision of premalignant vulvar lesions and immediate post-operative care.
1 surgery day visit and 1 phone call follow-up at 1 week
Duration - 4 to 6 weeks post-surgery
Participants have a physical exam to assess wound healing and complications after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Amanda Urban
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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