Comparing wound closure methods after C-sections
Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
This study is testing if a new way to close C-section wounds using special sutures and glue can help women feel better and heal more effectively compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | North York General Hospital Academic / other |
| Locations | 1 site (North York, Ontario) |
| Trial ID | NCT06614829 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of standard wound closure versus a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO in women undergoing cesarean delivery. Participants will complete established questionnaires to capture their experiences and outcomes following the procedure. The goal is to determine if the innovative closure method leads to better patient-reported experiences and outcomes compared to the standard approach.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are planning an elective C-section and have access to the necessary technology to participate.
Not a fit: Patients who require an unplanned emergency C-section or have conditions that may complicate their surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences and outcomes for women undergoing cesarean sections.
How similar studies have performed: Similar studies have shown promising results with innovative wound closure techniques, suggesting potential benefits in patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
North York, Ontario
- North York General Hospital — North York, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mark Fan, MHSc
- Email: humanera@nygh.on.ca
- Phone: 416-756-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.