Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

Официальное название

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes for Three Wound Closure Techniques in Joint Arthroplasty Patients: A Randomized, Controlled Trial

Обзор

The patients from the Department of Orthopaedics Center for Joint Replacement will be asked to participate in the study. These patients will be randomized to one of three wound closure products, Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Participants will be asked to take a photograph of the incision 4 days after surgery to submit via MyChart for review by the WVU Department of Dermatology Team. All patients will be evaluated at their regular 2-week, 6-week, and 3-month post-operative visits where clinical photographs will be submitted for independent review by the WVU Department of Dermatology Team to assess outcomes.

Вмешательства

• Процедура Sylke Adhesive Dressing
  Topical wound closure device, made from silk fibroin woven mesh coated with a pressure-sensitive acrylic adhesive.
• Процедура Exofin Skin Glue
  2-octil cyanoacrylate formulation, applied using a soft and flexible applicator.
• Процедура Suture Strip Plus
  Flexible wound closure strip designed for primary wound closure made up of macroporous non-woven polyamide with a pressure sensitive adhesive.

Первичные конечные точки

• Rate of allergic contact dermatitis (4 Days Post Op) [Срок оценки: 4 Days Post-Op]
• Rate of allergic contact dermatitis (2 Weeks Post Op) [Срок оценки: 2 Weeks Post-Op]
• Rate of allergic contact dermatitis (6 Weeks Post Op) [Срок оценки: 6 Weeks Post-Op]
• Rate of allergic contact dermatitis (3 Months Post Op) [Срок оценки: 3 Months Post-Op]

Вторичные конечные точки (4)

• Difference in Cosmetic Outcome (4 Days Post-Op) [Срок оценки: 4 Days Post-Op]
• Difference in Cosmetic Outcome (2 Weeks Post-Op) [Срок оценки: 2 Weeks Post-Op]
• Difference in Cosmetic Outcome (6 Weeks Post-Op) [Срок оценки: 6 Weeks Post-Op]
• Difference in Cosmetic Outcome (3 Months Post-Op) [Срок оценки: 3 Months Post-Op]

Критерии участия

Критерии включения

• Willing and able to sign the informed consent
• Patients presenting to the WVU Medicine Center for Joint Replacement who have a primary TKA or THA surgery scheduled
• Patients with surgical wounds closed by 2-0 vicryl and barbed, running v-loc suture (assessed in OR)
• Active MyChart account and the ability to take and upload a photo in that system

Критерии исключения

• Patients scheduled for a revision THA or revision TKA
• THA used for treatment of a fracture
• Patients participating in other studies that might have involve medications such as antibiotics

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

Лечение

Центры проведения

США · 1 центр

• West Virginia University — Morgantown

Публикации

• Zhao E, Tarkin IS, Moloney GB. Subcuticular Barbed Suture and Skin Glue Wound Closure Decreases Reoperation and Length of Stay in Geriatric Hip Fractures When Compared With Staples. J Am Acad Orthop Surg Glob Res Rev. 2021 Oct 4;5(10):e21.00205. doi: 10.5435/JAAOSGlobal-D-21-00205. PMID 34605793
• Ali E, Makhdom AM. Association of Surgical Adhesive and Glue System With Incidence of Allergic Dermatitis Post Unilateral and Staged Bilateral Total Knee Arthroplasty. Cureus. 2024 Apr 23;16(4):e58827. doi: 10.7759/cureus.58827. eCollection 2024 Apr. PMID 38654960
• Ricciardo BM, Nixon RL, Tam MM, Radic RR, Ricciardo BJ. Allergic Contact Dermatitis to Dermabond Prineo After Elective Orthopedic Surgery. Orthopedics. 2020 Nov 1;43(6):e515-e522. doi: 10.3928/01477447-20200827-01. Epub 2020 Sep 3. PMID 32882052
• Pannu CD, Farooque Md K. Allergic Contact Dermatitis to Octyl Cyanoacrylate Skin Glue After Surgical Wound Closure: A Systematic Review. Dermatitis. 2024 Sep-Oct;35(5):443-466. doi: 10.1089/derm.2023.0342. Epub 2024 Feb 21. PMID 38386590
• Kim D, Lee NR, Park SY, Jun M, Lee K, Kim S, Park CS, Liu KH, Choi EH. As in Atopic Dermatitis, Nonlesional Skin in Allergic Contact Dermatitis Displays Abnormalities in Barrier Function and Ceramide Content. J Invest Dermatol. 2017 Mar;137(3):748-750. doi: 10.1016/j.jid.2016.10.034. Epub 2016 Nov 5. No abstract available. PMID 27826010
• Zhang W, Xu J, Qu S, Peng H. The impact of allergic contact dermatitis on the inflammatory response and repair in wound healing process. Front Med (Lausanne). 2025 Feb 19;12:1524198. doi: 10.3389/fmed.2025.1524198. eCollection 2025. PMID 40046929
• Rouhani DS, Singh NK, Chao JJ, Almutairi A, Seradj MH, Badowski-Platz R, Toranto JD, Mofid MM. Superiority of a Silk Surgical Site Wound Closure Device over Synthetic Dressings. Plast Reconstr Surg. 2024 Dec 1;154(6):1233-1244. doi: 10.1097/PRS.0000000000011316. Epub 2024 Feb 7. PMID 38330504
• Rouhani DS, Singh NK, Chao JJ, Almutairi A, Badowski-Platz R, Seradj MH, Mofid MM. Silk Bioprotein as a Novel Surgical-Site Wound Dressing: A Prospective, Randomized, Single-Blinded, Superiority Clinical Trial. Aesthet Surg J Open Forum. 2023 Oct 20;5:ojad071. doi: 10.1093/asjof/ojad071. eCollection 2023. PMID 37899912

Идентификаторы

NCT: NCT06957444 · 2503134113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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