Recruiting

C-Section Wound Closure vs. STRATAFIX/DERMABOND

Sponsor:

North York General Hospital

Code:

NCT06614829

Conditions

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stratafix Suture

DERMABOND PRINEO

Study Details

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)

Study ID

NCT06614829

Start date

Oct 22, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Canadian Patient Experiences Survey - Inpatient Care + maternity questions [ Time Frame: Assessed roughly 48-72 hours after C-section delivery ]
  • SCAR-Q Scores [ Time Frame: Assessed at approximately 6 week follow-up appointment ]
  • Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment] [ Time Frame: Assessed at approximately 6 week follow-up appointment ]
  • Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment] [ Time Frame: Assessed at approximately 6 week follow-up appointment ]
  • Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment] [ Time Frame: Assessed at approximately 6 week follow-up appointment ]

Central Contacts and Locations

Central contacts

Mark Fan, MHSc

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

Locations

North York General Hospital

Recruiting

North York, Ontario, Canada, M2K1E1

Contacts

Mark Fan

416-756-6000clinicaltrials@nygh.on.ca

More Information

Sponsor

North York General Hospital

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North York General Hospital on 2024-11-29.