Clinical trial NCT06614829: Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
Official title: Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery)
Lead sponsor: North York General Hospital
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2024-09-26
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel between group study
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Canadian Patient Experiences Survey - Inpatient Care + maternity questions
timeFrame: Assessed roughly 48-72 hours after C-section delivery
measure: SCAR-Q Scores
timeFrame: Assessed at approximately 6 week follow-up appointment
measure: Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]
timeFrame: Assessed at approximately 6 week follow-up appointment
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
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
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
Study officials:
References: