[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539863":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":74,"collaborators":32,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":32,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":32,"enrollmentInfo":87,"targetDuration":32,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Nevada, Las Vegas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Closure with 0.1% Betaine\u002F0.1% Polyhexanide Wound Irrigation","ACTIVE_COMPARATOR","The ostomy wound will be irrigated with 0.1% Betaine\u002F0.1% Polyhexanide wound irrigation, then closed completely with sutures.",[13],"Drug: Primary Ostomy Closure with 0.1% Betaine\u002F0.1% Polyhexanide Wound Irrigation",{"label":15,"type":10,"description":16,"interventionNames":17},"Secondary Closure with Pursestring","The ostomy wound will be partially closed using the Pursestring method.",[18],"Procedure: Pursestring Closure",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Primary Ostomy Closure with 0.1% Betaine\u002F0.1% Polyhexanide Wound Irrigation","An elliptical transverse incision will be made extending 1-2 cm lateral and medial to the mucocutaneous junction. The mobilization, anastomosis and fascial closure will be performed as in the pursestring closure group. The incision will then be irrigated using direct stream into the wound with 350cc of Prontosan. After one minute the wound will be suctioned dry. The subcutaneous fat will be mobilized and approximated with interrupted 2-0 Vicryl. The skin will be approximated with deep dermal 3-0 Vicryl and a running subcuticular 4-0 Monocryl suture and Dermabond will be applied.",[9],[26],"Prontosan",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Pursestring Closure","A circular incision will be made at the mucocutaneous junction of the ileostomy. After complete mobilization of the ileal limbs off the fascia and a stapled side to side functional end to end anastomosis, the fascia including the external and posterior rectus sheath will be closed with two running #0 PDS (Polydioxanone) suture. The wound will then be irrigated with saline and partially closed in the subcuticular plane with a 2-0 Monocryl suture in a pursestring fashion and packed in the middle with plain packing.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Ovunc Bardakcioglu, MD","Kirk Kerkorian School of Medicine at UNLV","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Abigail W Cheng, MD","CONTACT","9166954159","abigail.cheng@unlv.edu",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Lance Horner, MD","7755445456","lance.horner@unlv.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University Medical Center","RECRUITING","Las Vegas","Nevada","89102","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-115.13722,36.17497,{"lat":61,"lon":60},[64,65,66,67,68,70,72],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},{"name":35,"role":37,"phone":32,"phoneExt":32,"email":32},{"name":45,"role":37,"phone":32,"phoneExt":32,"email":32},{"name":40,"role":69,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":71,"role":69,"phone":32,"phoneExt":32,"email":32},"Henry Krasner, BS",{"name":73,"role":69,"phone":32,"phoneExt":32,"email":32},"Kavita Batra, PhD",{"type":37,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Ovunc Bardakcioglu","Chief of Colorectal Surgery","100539863","phase-4-ostomy-primary-closure-with-01-betainepolyhexanide-wound-irrigation-compared-to-pursestring-closure-100539863",false,"NCT06309368","Ostomy Primary Closure With 0.1% Betaine\u002FPolyhexanide Wound Irrigation Compared to Pursestring Closure","To Close or Not to Close: Surgical Site Infection Rates in Ostomy Primary Closure With 0.1% Betaine\u002FPolyhexanide Wound Irrigation Compared to Conventional Ostomy Closure by Secondary Intention","Inclusion Criteria:\n\n* All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled\n* Signed consent\n\nExclusion Criteria:\n\n* Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy",true,"ALL","18 Years",{"count":88,"type":89},84,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are:\n\n1. Surgical site infection rates\n2. Patient quality of life\n3. Time to wound healing\n\nParticipants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above.",[95,96,97],"Surgical Site Infection","Wound Surgical","Colorectal Disorders",[99,95,100,101],"Ostomy","Primary Closure","Secondary Closure","2025-05-27",{"date":104,"type":105},"2025-06-02","ACTUAL",{"date":107,"type":105},"2024-03-14",{"date":109,"type":89},"2029-12",{"name":5,"class":6},1]