Non-Inferiority Analysis of Adhesive Strips Vs. Sutures in Lumbar Spinal Fusion: a Propensity Matched Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,016
- 试验地点
- 1
- 主要终点
- Surgical site infections
研究概览
简要总结
Comparison between two methods for skin closure in lumbar spinal fusion surgery, a non-inferiority approach between sutures and adhesive strips and its effect on surgical site infections.
详细描述
Surgical site infections (SSIs) are among the most common complications in spine surgery, the average rate of infection in spine surgery has been estimated to be around 2.1-3.1%, being the lumbar region the most prone to infection with a reported incidence of 3.7-6.9%. Wound management and the choice of materials used for skin closure can influence the rate of wound-related complications.
This work is a retrospective, mono-centric analysis of data collected for surgical site infections (SSIs) surveillance in patients with lumbar spinal fusion surgery, the primary outcome is surgical site infections rate in the cohort and its relation to the wound closure method (Adhesive strips vs sutures). Using a propensity score matching and a non-inferiority analysis the objective was to determined if adhesive strips is not inferior to sutures regarding SSIs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing spinal fusion surgery.
- •Open posterior approach.
- •Surgery involving one or two spinal segments.
- •Patients aged 18 years or older.
- •Skin closure performed using either sutures or adhesive strips.
排除标准
- •History of previous surgical site infections.
- •Diagnosis of spondylodiscitis.
- •Postoperative complications unrelated to surgical site infections.
- •Deep surgical site infections (A3 classification).
- •Patients undergoing surgeries other than lumbar spinal fusion.
结局指标
主要结局
Surgical site infections
时间窗: 30 days
Surgical site infections suspected by clinical signs, and confirmed by culture.
次要结局
未报告次要终点