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NOT YET RECRUITING
NCT07749495
NA

Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)

Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

View on ClinicalTrials.gov

Summary

The choice of skin closure (staples vs. monofilament sutures vs. barbed sutures/adhesive) is critical for wound healing quality in prosthetic surgery (hip and knee). The combination of barbed sutures (e.g., Stratafix) and skin glue (e.g., Dermabond) is promising (superior cosmetic outcome, no suture removal, antimicrobial barrier) but has been poorly evaluated prospectively and comparatively in orthopaedics, which justifies this study. The primary objective is to compare the wound healing success rate at two weeks postoperatively between the patient groups. The primary outcome measure is successful wound healing, defined as the absence of wound complications (wound dehiscence, seroma, hematoma, early postoperative infection) during the first two weeks

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-10-15

Completion Date

2027-12

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

PROCEDURE

primary knee replacement

For patients who have undergone knee replacement surgery (K), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group K1) to those closed with staples (Group K2).

PROCEDURE

Primary hip replacement.

For patients who have undergone hip replacement surgery (H), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group H1) to those closed with monofilament sutures (Group H2).