Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Sternal healing as measured by CT scan
研究概览
简要总结
Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative Inclusion Criteria
- •Adults (age range: 18-89)
- •Undergoing cardiac surgery through sternotomy
- •≥2 risk factors:
- •Diabetes mellitus
- •Severe COPD
- •Chronic steroid use
- •Immunosuppression
- •Redo sternotomy
- •Kidney disease with GFR >30 ml/min per 1.73m2
- •Radiation therapy
- •High-risk of delirium
- •Heavy alcohol use
- •Preoperative
排除标准
- •Active malignancy
- •Chronic narcotic use
- •NYHA Class IV
- •Known nickel metal allergy
- •Compliance concern
- •eGFR<30 ml/min per 1.73m2
- •Involvement in another interventional clinical trial (non-registry)
- •Any criteria precluding RPF or WC
- •Operative Inclusion Criteria
- •Off-midline sternotomy
- •BITA grafting
- •CPB time ≥120 minutes
- •Transverse sternal fracture
- •Operative Exclusion Criteria
- •Emergent or emergent salvage surgery
- •Non-standard sternotomies
- •Sternotomy with bony margin <2 mm
- •Delayed sternal closure
- •Surgical complications
- •Any criteria precluding RPF or WC
研究组 & 干预措施
Rigid Sternal Fixation
The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.
干预措施: Rigid Sternal Fixation (Device)
Wire Cerclage
The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together.
干预措施: Wire Cerclage (Device)
结局指标
主要结局
Sternal healing as measured by CT scan
时间窗: 6 months
5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).
Number of sternal wound complications as measured by patient/physician report
时间窗: 6 months
Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).
Total index hospitalization cost
时间窗: 6 months
Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
Total cost
时间窗: 6 months
All costs after initial discharge through 6 months
次要结局
- Change in pain as measured by the Wong-Baker pain scale(Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months)
- Change in prescribed narcotic use as measured by patient report(Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months)
- Change in upper extremity functional index (UEFI)(Discharge (up to 10 days), 1 month, 6 months)
- Change in quality of life as measured by the EuroQol EQ-5D-5L(Discharge (up to 10 days), 1 month, 6 months)
- Number of adverse events as measured by patient report(Up to 6 months)