The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants With Post-operative Infection (NPWT)
研究概览
简要总结
The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.
详细描述
This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= 18 years of age
- •>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
排除标准
- •< 18 years of age
- •< 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
- •Spinal infection at time of surgery
- •History of immunosuppression or chronic systemic infection
- •Pregnancy
- •Inability to provide informed consent
结局指标
主要结局
Number of Participants With Post-operative Infection (NPWT)
时间窗: 3 months
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
次要结局
未报告次要终点