NCT Number: NCT07749495
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: 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
Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 3 months postoperatively
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
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: 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.
Contact information is provided by the study sponsor or research team.
Groupe Hospitalier Diaconesses Croix Saint-Simon
Other
Acronym: Cica-Pro
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