Hip Arthroplasty, Knee Arthroplasty, Surgical Wound
Conditions
Keywords
Skin Closure in Prosthetic Joint Surgery
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
Interventions
PROCEDUREprimary 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).
PROCEDUREPrimary 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).
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Wound Healing at 2 Weeks Postoperatively | 2 weeks postoperatively | Proportion of patients with successful wound healing, defined as the complete absence of wound complications (dehiscence, seroma, hematoma, or early postoperative surgical site infection) during the first 2 postoperative weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity Stage of Wound Complications According to DISH Classification | 2 weeks postoperatively | Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale. |
| Patient-Reported Scar Aesthetic Quality Score | 3 months postoperatively | Assessment of the scar's aesthetic quality completed by the patient using a numerical rating scale from 0 to 100, where 0 represents the worst possible aesthetic outcome and 100 represents the best possible aesthetic outcome. Higher scores indicate greater aesthetic satisfaction. |
| Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS) | Change from baseline at Week 1 and Week 2 postoperatively | Patient self-reported anxiety level measured on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents "no anxiety" and 10 represents "extreme/worst possible anxiety". Higher scores indicate higher levels of anxiety. |
| Number of Unplanned Postoperative Wound-Related Medical Consultations | Through 3 months postoperatively | Total count of unplanned wound-related medical consultations (at outpatient clinics or emergency departments) per patient, as recorded in the patient follow-up logbook. |
| Direct Surgical Closure Material Cost per Patient | At the time of surgery (Day 0) | Direct cost (in Euros, EUR) of surgical wound closure materials (including sutures, staples, and skin glue) per patient. |
| Number of Wound-Related Postoperative Phone Calls | Through 3 months postoperatively | Total count of wound-related telephone calls made by the patient, as recorded in the patient follow-up logbook. |
| Postoperative Wound Care and Complication Management Costs per Patient | Through 3 months postoperatively | Direct medical costs (in Euros, EUR) for postoperative care, including dressing consumables, home nursing visits, and management of early wound complications per patient. |
| Change from Baseline in Patient Anxiety Evaluated by APAIS-C | Change from baseline at Week 1 and Week 2 postoperatively | Patient anxiety level evaluated using the modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-C). The anxiety subscale score ranges from 4 (minimum possible score) to 20 (maximum possible score). Higher scores indicate higher levels of anxiety. |
Contacts
CONTACTYounes KERROUMI, Clinical Research Physician
Outcome results
None listed