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

N/ANot Yet RecruitingNCT07749495

Groupe Hospitalier Diaconesses Croix Saint-Simon400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

400

Conditions

Surgical Wound Knee Arthroplasty Hip Arthroplasty

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of Successful Wound Healing at 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

Time frame: 2 weeks postoperatively

Secondary Outcomes

Severity Stage of Wound Complications According to DISH Classification

Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale.

Time frame: 2 weeks postoperatively

Patient-Reported Scar Aesthetic Quality Score

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.

Time frame: 3 months postoperatively

Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS)

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.

Time frame: Change from baseline at Week 1 and Week 2 postoperatively

Number of Unplanned Postoperative Wound-Related Medical Consultations

Total count of unplanned wound-related medical consultations (at outpatient clinics or emergency departments) per patient, as recorded in the patient follow-up logbook.

Time frame: Through 3 months postoperatively

Direct Surgical Closure Material Cost per Patient

Direct cost (in Euros, EUR) of surgical wound closure materials (including sutures, staples, and skin glue) per patient.

Time frame: At the time of surgery (Day 0)

Number of Wound-Related Postoperative Phone Calls

Total count of wound-related telephone calls made by the patient, as recorded in the patient follow-up logbook.

Time frame: Through 3 months postoperatively

Postoperative Wound Care and Complication Management Costs per Patient

Direct medical costs (in Euros, EUR) for postoperative care, including dressing consumables, home nursing visits, and management of early wound complications per patient.

Time frame: Through 3 months postoperatively

Change from Baseline in Patient Anxiety Evaluated by APAIS-C

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.

Time frame: Change from baseline at Week 1 and Week 2 postoperatively

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts