A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- infection rate
研究概览
简要总结
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gustilo type II-IIIa tibia fracture
- •age greater than 15 years
- •fractures amenable to intramedullary nailing
排除标准
- •excessive wound contamination
- •patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
- •impaired or absent consciousness
- •refusal of consent
研究组 & 干预措施
delayed closure
wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure.
干预措施: delayed closure (Procedure)
immediate wound closure
traumatic and surgical wounds closed at initial surgical intervention
干预措施: immediate wound closure (Procedure)
结局指标
主要结局
infection rate
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
hospital readmissions
need for additional procedures and hospital readmissions related to the index injury will be documented
tibial fracture healing
evidence of bridging callus on three of four cortices assessed by biplanar radiograph
次要结局
未报告次要终点