Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence rate of postoperative skin complications (allergic contact dermatitis, blistering, erythema)
研究概览
简要总结
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
详细描述
This is a prospective, randomized, parallel-group controlled trial conducted at a single academic medical center comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based skin closure system (Dermabond or Prineo) in patients undergoing primary or revision anterior cruciate ligament reconstruction (ACLR). Participants are randomized 1:1 using a computer-generated allocation sequence stratified by operating surgeon. Wound closure is standardized across all participants prior to dressing application, ensuring that deep and dermal closure are identical between groups and independent of allocation.
The primary outcome is the incidence of early postoperative skin complications, including allergic contact dermatitis, blistering, erythema, and other incision-related complications, assessed at the first postoperative visit (7-14 days). Secondary outcomes include patient-reported comfort, itch, incision-site pain, satisfaction, and rehabilitation interference at approximately 30 days; dressing-related complications requiring clinical intervention through 30 days, captured via blinded electronic medical record review; and scar quality at a minimum of 3 months postoperatively using the Patient and Observer Scar Assessment Scale (POSAS v2.0), with the observer component scored by one unblinded clinical assessor and two fully blinded independent raters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 60 years
- •Scheduled for primary or revision ACL reconstruction (ACLR)
- •Able and willing to provide informed consent (≥18 years) or assent with parental/guardian permission (ages 14-17)
- •Able and willing to comply with all study-related procedures and follow-up visits
排除标准
- •Active dermatologic conditions at or near the surgical site (e.g., eczema, psoriasis, dermatitis, open wounds)
- •Immunocompromised state (e.g., uncontrolled HIV, ongoing chemotherapy, chronic corticosteroid therapy)
- •Known or suspected allergy or hypersensitivity to silk fibroin or cyanoacrylate adhesives
- •Uncontrolled diabetes (defined as most recent HbA1c ≥ 8.0, if available; not measured for study purposes)
- •Active systemic infection at the time of enrollment
研究组 & 干预措施
Silk fibroin adhesive incision dressing
Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR).
干预措施: silk fibroin-based incision dressing (Device)
Standard closure dressing
Participants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon.
干预措施: cyanoacrylate-based closure system (Device)
结局指标
主要结局
Incidence rate of postoperative skin complications (allergic contact dermatitis, blistering, erythema)
时间窗: Follow-up 1 (7-14 days postoperatively)
次要结局
- Percentage of participants with intact dressing(Follow-up 2 (4-6 weeks postoperatively))
- Participant reported comfort rating as assessed by the Visual Analogue Scale (VAS)(Follow-up 2 (4-6 weeks postoperatively))
- Participant reported itch rating as assessed by the VAS(Follow-up 2 (4-6 weeks postoperatively))
- Rehabilitation Interference score(Follow-up 2 (4-6 weeks postoperatively))
- Overall participant satisfaction rating as assessed by the VAS(Follow-up 2 (4-6 weeks postoperatively))
- Participant perceived scar quality score as assessed by the Patient and Observer Scar Assessment Scale (POSAS)(~1 year postoperative)
- Number of dressing-related complications requiring intervention(Day 30)