NCT06614829 Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
| NCT ID | NCT06614829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | North York General Hospital |
| Condition | Cesarean Section; Complications, Wound, Infection (Following Delivery) |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2025-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patient must be 18 years of age or older at time of recruitment 2. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent. 3. Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires 4. Patients must speak and write in English as study questionnaires will only be provided in English 5. Patients must have coverage from the Ontario Health Insurance Plan (OHIP) Exclusion Criteria: 1. Patients assessed by the participating surgeon with any conditions that may compromise their: * Ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities) * Expectation of significant maternal complications that may affect the surgery 2. Patients who enroll in the study but have an unplanned emergency C-section