[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563335":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":12,"centralContacts":30,"locations":36,"responsibleParty":48,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":12,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":12,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"North York General Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","This group would be receiving the standard of care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Bundled C-section Wound Closure","ACTIVE_COMPARATOR","Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.",[18,19],"Device: Stratafix Suture","Device: DERMABOND PRINEO",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"DEVICE","Stratafix Suture","Stratafix sutures are barbed and have an antimicrobial coating. The barbs maintain tension during and allows for knotless suturing. The antimicrobial coating inhibits bacterial colonization of the wound.",[14],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"DERMABOND PRINEO","DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive. It also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure. It forms a strong, flexible, waterproof microbial barrier-as long as the adhesive film remains intact-that falls off naturally after 7-14 days.\n\nDermabond Prineo system will be applied to the skin for skin closure.",[14],[31],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Mark Fan, MHSc","CONTACT","416-756-6000","humanera@nygh.on.ca",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":12,"geoPoint":12,"contacts":44},"RECRUITING","North York","Ontario","M2K1E1","Canada","CA",[45],{"name":46,"role":33,"phone":34,"phoneExt":12,"email":47},"Mark Fan","clinicaltrials@nygh.on.ca",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Patricia Trbovich","Badeau Family Research Chair in Patient Safety and Quality Improvement",[53],{"name":54,"class":55},"Johnson & Johnson","INDUSTRY","100563335","patient-reported-experiences-and-outcomes-associated-with-standard-c-section-wound-closure-versus-stratafixdermabond-prineo-wound-closure-cs-preo-100563335",false,"NCT06614829","Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX\u002FDERMABOND PRINEO Wound Closure (CS-PREO)","Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle","CS-PREO","Inclusion Criteria:\n\n1. Patient must be 18 years of age or older at time of recruitment\n2. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.\n3. Patients must have internet access and\u002For a smartphone in order to access the digital platform to complete the study questionnaires\n4. Patients must speak and write in English as study questionnaires will only be provided in English\n5. Patients must have coverage from the Ontario Health Insurance Plan (OHIP)\n\nExclusion Criteria:\n\n1. Patients assessed by the participating surgeon with any conditions that may compromise their:\n\n   * Ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities)\n   * Expectation of significant maternal complications that may affect the surgery\n2. Patients who enroll in the study but have an unplanned emergency C-section","FEMALE","18 Years",{"count":67,"type":68},68,"ESTIMATED","INTERVENTIONAL",[71],"NA","The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.",[74],"Cesarean Section; Complications, Wound, Infection (Following Delivery)","2024-11-26",{"date":77,"type":78},"2024-11-29","ACTUAL",{"date":80,"type":78},"2024-10-22",{"date":82,"type":68},"2025-12",{"name":5,"class":6},1]