Stainless Steel Wire vs. Polydioxanone "PDS" at Sternal Closure in Children After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Sternal stability
研究概览
简要总结
comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection & cosmetic outcome
详细描述
Median sternotomy is considered to be the gold standard incision in cardiac surgery. Sternotomy has to be performed properly to avoid short- and long-term morbidity and mortality. The surgical technique is well established and certain principles are recognized to be crucial to minimize complications. The identification of the correct landmarks, midline tissue preparation, osteotomy with the avoidance of injury to underlying structures like pleura, pericardium and ectatic ascending aorta, and targeted bleeding control are important steps of the procedure. As important as the performance of a proper sternotomy is a correct sternal closure. An override or shift of the sternal edges has to be avoided by placing the wires at a proper distance from each other without injuring the thoracic pedicle. The two sternal halves have to be tightly re-approximated to facilitate healing of the bone and to avoid instability, which is a risk factor for wound infection. With a proper performance of sternotomy and sternal closure, instability and wound infections are rare and depend on patient-related risk factors . Conventional closure uses stainless steel wire sutures which may not be the ideal approach as sternal wound infection and mediastinitis are troublesome complications following this method which are major causes of morbidity and mortality of patients. Availability of delayed absorbable sutures such as polydioxanone sutures (PDS) for sternal closure allows us to test the efficacy of it in prevention of these complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants & children up to 5 years old underwent open heart surgery in Assiut University heart hospital
排除标准
- •Older than 5 years old
研究组 & 干预措施
stainless steel wire closure
conventional closure of median sternotomy by stainless steel wire
干预措施: Median sternotomy closure (sternal closure) (Procedure)
PDS sternal closure
closure of median sternotomy by PDS
干预措施: Median sternotomy closure (sternal closure) (Procedure)
结局指标
主要结局
Sternal stability
时间窗: up to 2 years
Comparison of incidence of sternal dehiscence \& instability between 2 groups this is done by clinical assessment(history \& examination) \& follow up chest x-rays
次要结局
- Wound infection(up to 2 years)
- cosmetic outcome (prominent wire)(up to 2 years)
研究者
Mostafa Ibrahim Mohammad AbdelHafeez
Resident
Assiut University
