Closed Suction Drain or Not After Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change in Hb level
研究概览
简要总结
Comparative randomised study to clarify which better to use or no use of closed suction drain system after total hip arthroplasty regarding amount of blood loss, need for blood transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early post-operative rehabilitation. Patients will be followed up for one month postoperative clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view plain x-ray of the hip).
详细描述
Total Hip Arthroplasty (THA) wounds are prone to formation of hematomas. Hematomas may increase the incision tension, leading to wound discharge and providing a good medium for bacteria, increase post-operative pain, limitation of range of motion of hip joint and prolong post-operative rehabilitation duration, also may cause ecchymosis, and tension vesicles around the surgical wound.
So use of closed suction drain system may reduce these complications. Nevertheless some recent studies have claimed that drainage can cause other complications and does not reduce hematoma formation and risk for infection. Furthermore, some studies have shown that drainage increase blood loss after THA which may both lead to increase blood transfusion requirements and provide an entry point for skin microorganisms.
Some other studies have found that no significance between use and non use of suction drain after THA.
So the investigators will take this issue for study a comparison between benefits and hazards of use and non use of suction drain after THA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total hip arthroplasty (THA)
排除标准
- •Revision cases
- •Uncontrolled bleeding tendency (prothrombin conc. Less than 70%)
- •History of deep venous thrombosis
- •Sever liver impairment (liver failure)
- •Sever renal impairment (S. creatinine more than 3)
研究组 & 干预措施
A(drain group)
patients of primary THA will have closed suction drain introduced intraoperative at surgical site
干预措施: closed suction drain (Device)
B(No drain group)
patients of primary THA will have the surgical wound be closed with no suction drain
干预措施: no suction drain (Procedure)
结局指标
主要结局
change in Hb level
时间窗: preoperative and 24 hrs postoperative
次要结局
- amount of blood loss(upto 24 hrs postoperative)
- amount of blood transfusion(upto 24 hrs postoperative)
研究者
Yasser E khalifa
professor doctor of orthopedic and traumatology
Assiut University