Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Rate of infection severity (superficial and deep infections)
研究概览
简要总结
The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.
详细描述
Surgical procedure:
- Standard median sternotomy and cannulation for cardiopulmonary bypass. All procedures will be performed on heparin bonded cardiopulmonary bypass circuits with a membrane oxygenator.
- Closure technique: Patients in our study will be divided into two groups: Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.
(Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. ) Control Group: Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Old age > 60 years old.
- •Uncontrolled hypertension and diabetes mellitus patients.
- •Obesity (BMI>30 kg/m2).
- •Female gender.
- •Osteoporosis of the sternum.
- •Chronic Obstructive Pulmonary Disease (COPD).
- •Steroid therapy or immunosuppression.
- •Intraoperative intra-aortic balloon pump (IABP) use.
- •Re-exploration for bleeding.
- •Long time of cardiopulmonary bypass (>180 minutes).
- •Redo cardiac surgery operation (elective )
排除标准
- •o Patients with known allergies to gentamicin.
- •Patients less than 18 years old.
- •Off-pump cardiac surgery.
- •Minimal invasive cardiac surgery.
- •Elevated serum creatinine level.
- •Emergent cases
- •Harvesting of Bilateral internal thoracic artery.
研究组 & 干预措施
gentamycin
Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum
干预措施: Gentamycin (Procedure)
control
Patients in this group sternum will be closed without application of local Gentamycin containing collagen
干预措施: bone wax (Procedure)
结局指标
主要结局
Rate of infection severity (superficial and deep infections)
时间窗: during first 3 months post operative
Incidence of adverse effects of gentamicin implants
时间窗: during first 3 months post operative
Length of hospital stay
时间窗: during first 3 months post operative
short-term surgical outcome checklist
时间窗: during first 3 months post operative
Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure.
assess degree of healing
时间窗: after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale
non contrast C.T.chest done to assess degree of healing by The 6-Point CT Score (Stacy Score): 0 Non-union No evidence of bone bridging; wide gap. 1. Minimal union Rare/slight bone bridging across the osteotomy. 2. Mild union Less than 25% bone bridging. 3. Moderate union 25% to 50% bone bridging. 4. Near-complete More than 50% bone bridging with high stability. 5. Complete union Sternal halves well-aligned; no perceptible gap; looks like normal bone.
次要结局
未报告次要终点
研究者
Amr Elsayed Tawfek Ibrahim
ass prof
Zagazig University