Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro) | NCT07749495

NCT07749495

Overview

NCT ID: NCT07749495
Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-SimonOTHER
Official Title: Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)
Brief 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
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Men and women aged over 18 years

Patient who has provided written informed consent in duplicate

Patient scheduled for a primary hip or knee prosthesis implantation

BMI < 30 kg/m²

Non-smoker or smoking cessation for more than 4 weeks

Patient able to read and understand French

Patient with sufficient cognitive capacity to strictly follow study instructions (completion of the calendar)

Exclusion Criteria:

Patient expresses opposition to participating in the study

Patients under 18 years of age

Patient scheduled for prosthesis revision surgery

History of osteoarticular or soft-tissue infection

Diabetes, cardiovascular disease, immunodeficiency, or immunosuppressive treatment

Consumption of drugs, tobacco, or alcohol

Allergy to nickel (staples) or adhesive

History of anxiety disorders (generalized anxiety disorder, panic disorder, specific phobia, agoraphobia, social anxiety, separation anxiety), obsessive compulsive disorder (OCD), or post-traumatic stress disorder (PTSD)

Patient unable to read and/or understand French

Individuals deprived of liberty by judicial or administrative decision

Adults unable to consent or incapable of expressing consent

Subjects not affiliated with or not benefiting from a social security scheme

Pregnant or breastfeeding women

Central Contacts: Younes KERROUMI, Clinical Research PhysicianContact
ykerroumi@hopital-dcss.org

Participant Group/Arms

Group K1: Knee prosthesis, closed with barbed sutures and skin glue.Experimental

A group of patients who received a knee prosthesis (K) and whose wound was closed using barbed sutures and skin glue (Group K1).

Procedure: primary knee replacement

Group K2: Knee prosthesis, closed with staples.Active Comparator

A group of patients who received a knee prosthesis (K) and whose wound was closed using staples (Group K2).

Procedure: primary knee replacement

Group H1: Hip prosthesis, closed with barbed sutures and skin glue.Experimental

A group of patients who received a hip prosthesis (H) and whose wound was closed with barbed suture and skin glue (group H1).

Procedure: Primary hip replacement.

Group H2: Hip prosthesis, closed with monofilament suture.Active Comparator

A group of patients who received a hip prosthesis (H) and whose wound was closed using monofilament sutures (Group H2).

Procedure: Primary hip replacement.

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