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

Обзор

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

Вмешательства

• Процедура primary 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).
• Процедура Primary 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).

Первичные конечные точки

• Rate of Successful Wound Healing at 2 Weeks Postoperatively [Срок оценки: 2 weeks postoperatively]

Вторичные конечные точки (8)

• Severity Stage of Wound Complications According to DISH Classification [Срок оценки: 2 weeks postoperatively]
• Patient-Reported Scar Aesthetic Quality Score [Срок оценки: 3 months postoperatively]
• Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS) [Срок оценки: Change from baseline at Week 1 and Week 2 postoperatively]
• Number of Unplanned Postoperative Wound-Related Medical Consultations [Срок оценки: Through 3 months postoperatively]
• Direct Surgical Closure Material Cost per Patient [Срок оценки: At the time of surgery (Day 0)]
• Number of Wound-Related Postoperative Phone Calls [Срок оценки: Through 3 months postoperatively]
• Postoperative Wound Care and Complication Management Costs per Patient [Срок оценки: Through 3 months postoperatively]
• Change from Baseline in Patient Anxiety Evaluated by APAIS-C [Срок оценки: Change from baseline at Week 1 and Week 2 postoperatively]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Benkovich V, Abialevich A, Benkovich G. Clinical outcomes of closuring technique in total hip arthroplasty and total knee arthroplasty: A comparative study of staples technique vs triclosan-coated barbed sutures. Rev Esp Cir Ortop Traumatol. 2025 Nov-Dec;69(6):621-626. doi: 10.1016/j.recot.2025.03.006. Epub 2025 Mar 27. English, Spanish. PMID 40157721
• Russo A, Centola M, Nicodemo A, Masse A. The Use of Barbed Sutures in Total Hip Arthroplasty: A Systematic Review on Clinical-Surgical Outcomes, Costs, and Complications. Healthcare (Basel). 2024 May 23;12(11):1063. doi: 10.3390/healthcare12111063. PMID 38891138
• Liu T, Tao Y, Zhao R, Hua Y, Feng Z, Zheng Q, Zhang G, Geng L, Fu J, Qian W, Ni M, Wang W. Comparison of the safety and efficacy of three superficial skin closure methods for multi-layer wound closure in total knee arthroplasty: a multicenter, prospective, randomized controlled trial. Arthroplasty. 2024 Sep 11;6(1):51. doi: 10.1186/s42836-024-00271-1. PMID 39261893
• Khlopas A, Sodhi N, Anis HK, Ehiorobo J, Sultan AA, Mont MA. A Systematic Review of Suture Technologies in Total Knee Arthroplasty. Surg Technol Int. 2019 May 15;34:391-396. PMID 30664226
• Fillingham YA, Matonick JP, Mendoza V, Parvizi J. Comparing the Water-Tight Closure of Barbed and Conventional Suture Under Static and Dynamic Conditions in an Ex-Vivo Human Knee Arthrotomy Model. Arthroplast Today. 2021 Oct 14;12:1-6. doi: 10.1016/j.artd.2021.08.003. eCollection 2021 Dec. PMID 34703862
• Ainslie-Garcia MH, Anderson LA, Bloch BV, Board TN, Chen AF, Craigie S, Danker W 3rd, Gunja N, Harty J, Hernandez VH, Lebedeva K, Hameed D, Mont MA, Nunley RM, Parvizi J, Perka C, Piuzzi NS, Rolfson O, Rychlik J, Romanini E, Sanz-Ruiz P, Sierra RJ, Suleiman L, Tsiridis E, Vendittoli PA, Wangen H, Zagra L. Identifying Critical Evidence Gaps in Wound Closure and Incision Management After Total Knee PMID 38972434

Идентификаторы

NCT: NCT07749495 · GHDCSS_RIPH1_ORTHO_3_2025 · 2025-A02223-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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