Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin … (NCT07749495) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)
400 participantsStarted 2026-10-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Successful Wound Healing at 2 Weeks Postoperatively