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

NARecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 22, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Interventions
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."

Trial Locations (1)

M2K1E1

RECRUITING

North York General Hospital, North York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Johnson & Johnson

INDUSTRY

lead

North York General Hospital

OTHER