Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Rate of Successful Wound Healing at 2 Weeks Postoperatively
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Group K1: Knee prosthesis, closed with barbed sutures and skin glue.
A group of patients who received a knee prosthesis (K) and whose wound was closed using barbed sutures and skin glue (Group K1).
干预措施: primary knee replacement (Procedure)
Group K2: Knee prosthesis, closed with staples.
A group of patients who received a knee prosthesis (K) and whose wound was closed using staples (Group K2).
干预措施: primary knee replacement (Procedure)
Group H1: Hip prosthesis, closed with barbed sutures and skin glue.
A group of patients who received a hip prosthesis (H) and whose wound was closed with barbed suture and skin glue (group H1).
干预措施: Primary hip replacement. (Procedure)
Group H2: Hip prosthesis, closed with monofilament suture.
A group of patients who received a hip prosthesis (H) and whose wound was closed using monofilament sutures (Group H2).
干预措施: Primary hip replacement. (Procedure)
结局指标
主要结局
Rate of Successful Wound Healing at 2 Weeks Postoperatively
时间窗: 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
次要结局
- Severity Stage of Wound Complications According to DISH Classification(2 weeks postoperatively)
- Patient-Reported Scar Aesthetic Quality Score(3 months postoperatively)
- Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS)(Change from baseline at Week 1 and Week 2 postoperatively)
- Number of Unplanned Postoperative Wound-Related Medical Consultations(Through 3 months postoperatively)
- Direct Surgical Closure Material Cost per Patient(At the time of surgery (Day 0))
- Number of Wound-Related Postoperative Phone Calls(Through 3 months postoperatively)
- Postoperative Wound Care and Complication Management Costs per Patient(Through 3 months postoperatively)
- Change from Baseline in Patient Anxiety Evaluated by APAIS-C(Change from baseline at Week 1 and Week 2 postoperatively)