Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Study Details
Study Description
Brief Summary
Primary:
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To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Primary:
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To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- the rate of perioperative vulvovaginitis [8 weeks]
To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
- rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown [8 weeks]
To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must be 18 years of age
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Has histologically confirmed non-malignant vulvar pathology
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Is scheduled or planning for WLE/SPV
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Signed informed consent obtained prior to any protocol specific procedures
Exclusion Criteria:
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Unable to give informed consent
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Women who are pregnant or nursing (lactating) women at time of consent
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No prior RT
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No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
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No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
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Not immunosuppressed or compromised
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No active HIV (must have undetectable viral load)
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Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
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No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
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Uncontrolled diabetes mellitus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- University of Virginia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSR230407