Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)

Not Applicable

Recruiting

• Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery)
• Interventions: Device: Stratafix Suture; Device: DERMABOND PRINEO

• Registration Number: NCT06614829
• Lead Sponsor: North York General Hospital

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.

Detailed Description

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.

Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2024-10-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bundled C-section Wound Closure	Stratafix Suture	Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.
Bundled C-section Wound Closure	DERMABOND PRINEO	Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.

Primary Outcome Measures

Name	Time	Method
Canadian Patient Experiences Survey - Inpatient Care + maternity questions	Assessed roughly 48-72 hours after C-section delivery	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
SCAR-Q Scores	Assessed at approximately 6 week follow-up appointment	Validated patient reported outcome measure (PROM) assessing three domains: 1) Scar appearance, 2) Scar Symptoms, and 3) Psychosocial Impact
Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]	Assessed at approximately 6 week follow-up appointment	Categories include: no, superficial, deep, organ/space
Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]	Assessed at approximately 6 week follow-up appointment	Self-reported by patient
Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]	Assessed at approximately 6 week follow-up appointment	Self-reported by patient

Trial Locations

Locations (1)

North York General Hospital; 🇨🇦 North York, Ontario, Canada