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NCT07749495
Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)
Conditions: Surgical Wound, Knee Arthroplasty, Hip Arthroplasty
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
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
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
Source: ClinicalTrials.gov (NCT07749495). StuddyBuddy aggregates publicly available trial information.