A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of participant enrollment
研究概览
简要总结
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients 18-80 years old
- •Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
- •Incisions must be able to be approximated with subdermal sutures intraoperatively
- •English and Spanish speaking patients only
排除标准
- •Open fractures
- •Incarcerated patients
- •Pregnant patients
- •Patients who do not speak English or Spanish
- •History of infection at surgical incision site at the time of definitive fixation
- •Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
- •Unable to obtain consent from patient prior to surgery or from legally authorized representative (LAR) prior to skin closure if the patient is unable to consent dur to their medical condition.
- •The absence of a subcutaneous closure during the index procedure
研究组 & 干预措施
Suture
Wound Closure
干预措施: Suture (Other)
Staple
Wound Closure
干预措施: Staple (Other)
结局指标
主要结局
Feasibility of participant enrollment
时间窗: 12 Months
- Hitting target enrollment in 12 months, enrolling 50% of eligible patients
Feasibility of randomization to each of the treatments
时间窗: 6 Months
- Rate of consent
Assess Protocol Compliance
时间窗: 6 Months
* Percentage of survey completion * Percentage of follow-up * Percentage of completed planned outcomes measures
次要结局
未报告次要终点
研究者
Joshua Gary
Associate Professor
University of Southern California