Nctid:
NCT06614829
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Wound", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Parallel between group study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>68}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-10-22", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-26", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Canadian Patient Experiences Survey - Inpatient Care + maternity questions", "timeFrame"=>"Assessed roughly 48-72 hours after C-section delivery", "description"=>"Validated patient reported experience measure (PREM) assessing 1) communication with nurses, 2) communication with doctors, 3) involvement in decision-making and treatment options, 4) information and understanding when leaving the hospital, and 5) overall hospital experience"}, {"measure"=>"SCAR-Q Scores", "timeFrame"=>"Assessed at approximately 6 week follow-up appointment", "description"=>"Validated patient reported outcome measure (PROM) assessing three domains: 1) Scar appearance, 2) Scar Symptoms, and 3) Psychosocial Impact"}, {"measure"=>"Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]", "timeFrame"=>"Assessed at approximately 6 week follow-up appointment", "description"=>"Categories include: no, superficial, deep, organ/space"}, {"measure"=>"Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]", "timeFrame"=>"Assessed at approximately 6 week follow-up appointment", "description"=>"Self-reported by patient"}, {"measure"=>"Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]", "timeFrame"=>"Assessed at approximately 6 week follow-up appointment", "description"=>"Self-reported by patient"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Cesarean Section; Complications, Wound, Infection (Following Delivery)"]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo.\n\nPatients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"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/or 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"}, "identificationModule"=>{"nctId"=>"NCT06614829", "acronym"=>"CS-PREO", "briefTitle"=>"Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)", "organization"=>{"class"=>"OTHER", "fullName"=>"North York General Hospital"}, "officialTitle"=>"Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle", "orgStudyIdInfo"=>{"id"=>"0434"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"This group would be receiving the standard of care."}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Bundled C-section Wound Closure", "description"=>"Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.", "interventionNames"=>["Device: Stratafix Suture", "Device: DERMABOND PRINEO"]}], "interventions"=>[{"name"=>"Stratafix Suture", "type"=>"DEVICE", "description"=>"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.", "armGroupLabels"=>["Bundled C-section Wound Closure"]}, {"name"=>"DERMABOND PRINEO", "type"=>"DEVICE", "description"=>"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.", "armGroupLabels"=>["Bundled C-section Wound Closure"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"M2K1E1", "city"=>"North York", "state"=>"Ontario", "status"=>"RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Mark Fan", "role"=>"CONTACT", "email"=>"clinicaltrials@nygh.on.ca", "phone"=>"416-756-6000"}], "facility"=>"North York General Hospital", "geoPoint"=>{"lat"=>43.76681, "lon"=>-79.4163}}], "centralContacts"=>[{"name"=>"Mark Fan, MHSc", "role"=>"CONTACT", "email"=>"humanera@nygh.on.ca", "phone"=>"416-756-6000"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Only aggregate data will be shared comparing study arms."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"North York General Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Johnson & Johnson", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Badeau Family Research Chair in Patient Safety and Quality Improvement", "investigatorFullName"=>"Patricia Trbovich", "investigatorAffiliation"=>"North York General Hospital"}}}}
