跳至主要内容
临床试验/NCT03343990
NCT03343990Unknown不适用

Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure Post Open Heart Surgery in Egyptian Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Healing of the sternum

研究概览

简要总结

Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients

详细描述

Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients

Midline sternotomy, first described by Milton in 1887 [4,7,8] remains the most popular technique of cardiac exposure because of its quick and easy performance, excellent access to the heart and great vessels. Effective prevention methods for disruption and infection of median sternotomy continue to be debated. The most important factor in preventing PSWC is a stable sternal approximation, as bony union depends on adequate reduction and immobilization of the stern costal junctions. Strict adherence of preoperative aseptic technique is crucial. Careful attention to homeostasis and meticulous surgical technique remain the mainstays of prevention and must include precise sternal alignment and stable closure. While biomechanical studies appear to be valid, their general value is limited Different sternal closure techniques

  1. Trans-sternal/peristernal wiring
  2. Bilateral and longitudinal parasternal running wires (described by Robicsek)
  3. Double wires
  4. Steel band
  5. Figure of eight The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture .
  6. Interlocking multi-twisted wires One of recent way in closure of sternal gives more stabilization. At least 6 wires have to be passed. The wires should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other the wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends buried

6- Alternative techniques

Techniques utilizing lateral sternal support are first-line options in preventing SD and wound infections. The need to provide lateral reinforcement of the sternum has led to the development of several techniques, such as A-the use of lateral staples and lateral plates B-H-shaped titanium plates C- Reinforced sternal closure system D-thermo reactive clips E- Rigid plate fixation change

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
17 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient above 16 years undergoing open heart surgery with sternotomy
  • Patient is willing to comply with all follow-up visits.
  • Willing and able to provide written informed consent and comply with study requirements

排除标准

  • Pediatric patients below 16 years
  • Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.

结局指标

主要结局

Healing of the sternum

时间窗: 60 days

Duration of complete healing of the sternum :By 1. Radiological (chest x-ray ant-post view and lat view in first 6 weeks post-operative 2. Clinical examination in first 6 weeks post operative

次要结局

  • mobilization(45 days)
  • rate of wound infection(30 days)
  • Time of procedure(45 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Rabee Hamed Ahmed

sternal closure

Assiut University

研究点 (1)

Loading locations...

相似试验