[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521504":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Virginia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Positive Perioperative Vaginitis","EXPERIMENTAL","Participants who test positive for BV, candida, and\u002For trichomonas on perioperative vaginitis swab.",[13],"Diagnostic Test: Vaginitis panel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Vaginitis panel","vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Amanda Urban","CONTACT","434.409.3100","AJR5Y@uvahealth.org",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Charlottesville","Virginia","22908","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-78.47668,38.02931,{"lat":39,"lon":38},[42,46,49],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Amanda Urban, MS","434-409-3100","ajr5y@virginia.edu",{"name":47,"role":24,"phone":20,"phoneExt":20,"email":48},"Carrie Sopata, MD","ces9cz@uvahealth.org",{"name":47,"role":50,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Carrie Sopata","Associate Professor","100521504","prospective-evaluation-of-infectious-vulvovaginitis-on-wound-complication-rates-after-vulvar-excision-for-premalignant-lesions-100521504",false,"NCT06070454","Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions","Inclusion Criteria:\n\n* Must be 18 years of age\n* Has histologically confirmed non-malignant vulvar pathology\n* Is scheduled or planning for WLE\u002FSPV\n* Signed informed consent obtained prior to any protocol specific procedures\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Women who are pregnant or nursing (lactating) women at time of consent\n* No prior RT\n* No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)\n* No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation\n* Not immunosuppressed or compromised\n* No active HIV (must have undetectable viral load)\n* Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed\n* No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease\n* Uncontrolled diabetes mellitus","FEMALE","18 Years",{"count":63,"type":64},91,"ESTIMATED","INTERVENTIONAL",[67],"NA","Primary:\n\n* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision\n* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV\u002FWLE 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.",[70,71],"Vaginitis","Vulvar Diseases","2025-10-16",{"date":74,"type":75},"2025-10-20","ACTUAL",{"date":77,"type":75},"2024-04-25",{"date":79,"type":64},"2026-08-01",{"name":5,"class":6},1]