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

NCT06614829 | Recruiting FDA Device

• 1 other identifier: 0434
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control

NO INTERVENTION

This group would be receiving the standard of care.

Bundled C-section Wound Closure

ACTIVE COMPARATOR

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

Device: Stratafix Suture; Device: DERMABOND PRINEO

Interventions

Stratafix Suture DEVICE

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.

Bundled C-section Wound Closure

DERMABOND PRINEO DEVICE

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.

Bundled C-section Wound Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 years of age or older at time of recruitment
• Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
• Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
• Patients must speak and write in English as study questionnaires will only be provided in English
• Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

You may not qualify if:

• 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
• Patients who enroll in the study but have an unplanned emergency C-section

Sponsors & Collaborators

• North York General Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (1)

North York General Hospital

North York, Ontario, M2K1E1, Canada

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Infections

Central Study Contacts

Mark Fan, MHSc

CONTACT

416-756-6000; humanera@nygh.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Badeau Family Research Chair in Patient Safety and Quality Improvement

Model Details: Parallel between group study

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)