Sternal Closure Techniques in High-BMI Patients Undergoing Open-Heart Surgery: A Retrospective Observational Comparison of Cable and Wire Systems
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of Sternal Instability and Major Wound Complications
研究概览
简要总结
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020, and December 31, 2024. The study aims to evaluate the incidence of sternal instability, wound infections, reoperation, and length of stay in the intensive care unit and hospital. Findings may help inform surgical decision-making for high-BMI patients.
详细描述
Elevated body-mass index (BMI ≥ 30 kg/m²) is an established risk factor for sternal wound complications after median sternotomy, yet consensus is lacking on the optimal closure technique in this high-risk subgroup. Conventional monofilament stainless-steel wiring remains the worldwide standard because it is inexpensive and familiar, but multifilament cable systems provide greater fatigue strength and more uniform load distribution in bench testing and early clinical reports. Previous meta-analyses report conflicting results-some indicating fewer sternal complications with rigid fixation, others showing no clear benefit-largely because they pool heterogeneous populations in which obesity is often only one of many overlapping risk factors. The present study isolates the effect of BMI by retrospectively analysing all adult patients (≥18 years) with BMI ≥ 30 kg/m² who underwent primary open-heart surgery at a single tertiary centre from 1 January 2020 through 31 December 2024. Patients are stratified by the sternal closure method actually used-standard simple/figure-of-eight wires versus a commercially available rigid cable system (RTI Surgical Sternal Cable). By excluding other indications for rigid fixation (eg, age ≥ 80, dialysis, osteoporosis, COPD, bilateral internal mammary harvest, mediastinitis, early re-exploration, re-do sternotomy), the analysis aims to discern whether obesity alone modifies the relative performance of the two techniques. De-identified peri-operative data are extracted from electronic records under institutional ethics approval, and pre-specified statistical comparisons will quantify associations between closure method and postoperative sternal instability, surgical site infection, need for reoperation, and resource utilisation (ICU and total hospital length of stay). Findings are expected to refine evidence-based recommendations for sternal closure in high-BMI cardiac-surgery patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Body Mass Index (BMI) ≥30 kg/m²
- •Underwent primary open-heart surgery via median sternotomy
- •Sternal closure performed with either standard stainless-steel wire or multifilament sternal cable system
- •Complete and accessible perioperative clinical records
排除标准
- •Age ≥80 years
- •End-stage renal disease or chronic hemodialysis
- •Redo sternotomy
- •Early postoperative re-exploration (within 7 days)
- •Mediastinitis prior to index discharge
- •Diabetic patients with bilateral internal mammary artery (IMA) harvest
- •Diagnosed osteoporosis
- •Chronic obstructive pulmonary disease (FEV₁ <80% and FEV₁/FVC <70%)
结局指标
主要结局
Incidence of Sternal Instability and Major Wound Complications
时间窗: 90 days after surgery
This outcome measures the rate of sternal instability (e.g., dehiscence, nonunion, displacement requiring intervention) and major sternal wound complications (e.g., deep sternal wound infection, mediastinitis, or reoperation for closure failure) in patients with BMI ≥30 undergoing open-heart surgery. The results will be compared between patients whose sternum was closed with standard stainless-steel wire versus those treated with a multifilament sternal cable system.
次要结局
- Intensive Care Unit Length of Stay(Postoperative Day 0 through ICU discharge, up to 14 days)
- Total Hospital Length of Stay(Postoperative Day 0 through hospital discharge, up to 30 days)
- Reoperation Not Related to Sternal Closure Failure(30 days postoperatively)
