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Trial Title:
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
NCT ID:
NCT06070454
Condition:
Vaginitis
Vulvar Diseases
Conditions: Official terms:
Precancerous Conditions
Vaginitis
Vulvovaginitis
Vulvar Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Vaginitis panel
Description:
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial
vaginosis (BV), trichomonas, and candida
Arm group label:
Positive Perioperative Vaginitis
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.
Detailed 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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Lacy, MPH
Phone:
434-243-0126
Email:
rmc9p@virginia.edu
Contact backup:
Last name:
Alice Chen, MD
Start date:
April 25, 2024
Completion date:
August 1, 2026
Lead sponsor:
Agency:
University of Virginia
Agency class:
Other
Source:
University of Virginia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06070454
