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

Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery)
• Intervention / Treatment: Device: Stratafix Suture; Device: 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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Fan, MHSc; Phone Number: 416-756-6000; Email: humanera@nygh.on.ca

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M2K1E1
      • Recruiting
      • North York General Hospital
      • Contact: Mark Fan; Phone Number: 416-756-6000; Email: clinicaltrials@nygh.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This group would be receiving the standard of care.
Active Comparator: Bundled C-section Wound Closure; Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.	Device: Stratafix Suture; Stratafix sutures are barbed and have an antimicrobial coating. The barbs maintain tension during and allows for knotless suturing. The antimicrobial coating inhibits bacterial colonization of the wound.; Device: DERMABOND PRINEO; DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive. It also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure. It forms a strong, flexible, waterproof microbial barrier-as long as the adhesive film remains intact-that falls off naturally after 7-14 days. Dermabond Prineo system will be applied to the skin for skin closure.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: North York General Hospital
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared comparing study arms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes