Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery

Официальное название

Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh a Randomized Controlled Trial to Evaluate Hypersensitivity Reactions in Shoulder Surgery

Обзор

The purpose of this study is to document the incidence of allergic contact dermatitis (ACD) to silk fibroin and 2-octyl cyanoacrylate mesh dressings after open shoulder surgery, to identify differences in clinic utilization for complications related to silk fibroin and 2-octyl cyanoacrylate mesh dressings and to collect patient reported outcome measures (PROMs) related to patient comfort and satisfaction for silk fibroin and 2-octyl cyanoacrylate mesh dressings.

Подробное описание

Multiple studies have demonstrated allergic contact dermatitis (ACD) to the Dermabond PRINEO skin closure system (Ethicon, Sommerville, NJ) that utilizes a 2-octyl cyanoacrylate liquid adhesive with a polyester mesh. This dressing is commonly applied after total hip (THA), total knee (TKA), and total shoulder arthroplasty (TSA) as an alternative or adjunct to staples or a subcuticular suture. However, 2-octyl cyanoacrylate mesh is documented to cause an allergic hypersensitivity reaction in 4-5% of patients. Risk factors include a documented contact allergy to medical adhesives and sensitization to 2-octyl cyanoacrylate mesh from a prior surgery. While this ACD generally resolves with dressing removal, corticosteroids, and observation, there are reports of severe reactions to Dermabond PRINEO requiring wound debridement and skin grafting. Despite this complication, Dermabond PRINEO is still one of the most commonly used postoperative dressings in orthopedic surgery. A silk fibroin (SYLKE, La Jolla, CA) dressing has recently been developed as an alternative surgical wound dressing. Two retrospective studies have evaluated the silk dressing compared to cyanoacrylate mesh after THA/TKA. Aastroem et al and Moo Young et al both demonstrated a 0% incidence of ACD with the use of a silk dressing. There is currently no additional evidence to support the use of silk fibroin dressings in orthopedic surgery outside of the total hip and knee literature. Our study will be a randomized controlled trial to prospectively evaluate hypersensitivity reactions to silk fibroin and 2-octyl cyanoacrylate mesh dressings in open shoulder surgery.

Вмешательства

• Устройство Silk fibroin (SYLKE)
  SYLKE dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.
• Устройство 2-octyl cyanoacrylate mesh (Dermabond PRINEO)
  Dermabond PRINEO dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.

Первичные конечные точки

• Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination [Срок оценки: at the time of dressing removal, which is about 10-14 days after the operation]

Вторичные конечные точки (3)

• Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications [Срок оценки: 6 weeks after the operation]
• Patients comfort as assessed by question 6 on the wound experience questionnaire [Срок оценки: 2 weeks after the operation]
• Patients satisfaction as assessed by question 7 on the wound experience questionnaire [Срок оценки: 2 weeks after the operation]

Критерии участия

Критерии включения

• open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.

Критерии исключения

• Prior documented medical adhesive contact allergy.
• Negative pressure wound dressings.
• Any procedure involving a wound problem at the planned surgical site.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07573202 · HSC-MS-26-0115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗