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

North York General Hospital

Status: Enrolling

Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery)

Treatments: Device: Stratafix Suture; Device: DERMABOND PRINEO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06614829

0434

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Control

No Intervention group

Description:

This group would be receiving the standard of care.

Bundled C-section Wound Closure

Active Comparator group

Description:

Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.

Treatment:

Device: DERMABOND PRINEO

Device: Stratafix Suture