[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521355":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Closed incision negative pressure wound therapy","EXPERIMENTAL","At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days.",[13],"Device: Closed incision negative pressure wound therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard dressing","ACTIVE_COMPARATOR","At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers.",[19],"Device: Standard dressing",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.",[15],[30],{"name":31,"affiliation":32,"role":33},"Tobias Haltmeier, MD","Inselspital, Bern University Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","31 664 03 04","+41","tobias.haltmeier@insel.ch",[41],{"facility":32,"status":25,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Bern","3010","Switzerland","CH",{"type":47,"coordinates":48},"Point",[49,50],7.44744,46.94809,{"lat":50,"lon":49},[53],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[57],{"name":58,"class":59},"Clinical Trials Unit University of Bern","UNKNOWN","100521355","closed-incision-negative-pressure-wound-therapy-for-the-prevention-of-surgical-site-infections-in-abdominal-surgery-100521355",false,"NCT06068517","Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery","Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial","CISSI","Inclusion Criteria:\n\n* Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations\n* Incision length ≥ 10 cm\n* Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)\n* Abdominal closure with or without mesh implantation\n* Primary abdominal closure or closure after open abdomen treatment\n* Age over 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n* CDC wound class 4 (dirty\u002Finfected wound)\n* Organ transplantation\n* Sensitivity or allergy to silver",true,"ALL","19 Years",{"count":72,"type":73},654,"ESTIMATED","INTERVENTIONAL",[76],"NA","Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.",[79],"Surgical Wound Infection","NOT_YET_RECRUITING","2024-12-04",{"date":83,"type":84},"2024-12-05","ACTUAL",{"date":86,"type":73},"2026-03-01",{"date":88,"type":73},"2028-05-31",{"name":5,"class":6},1]