Randomized Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac surgery patients at high risk for sternal wound complications. The investigators have designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of kryptonite to conventional closure. The primary outcome will be quality of life. Secondary outcomes include sternal complications, pain, hospital length of stay, and respiratory function.
详细描述
Purpose: To compare clinical outcomes following sternal closure with Kryptonite and conventional sternal closure, in cardiac surgery patients at high risk for sternal wound complications.
Hypothesis: Patients receiving sternal closure with Kryptonite will have a shorter post-operative length of stay, fewer sternal wound complications, improved respiratory function, better quality of life, and less pain than patients receiving a conventional sternal closure. The investigators hypothesize that patients receiving sternal closure with Kryptonite will be discharged from hospital, on average, 1 day earlier than patients receiving conventional sternal closure.
Justification: Kryptonite is a biologic polymer from the castor bean and is non-toxic. It is osteoconductive i.e. bone regrows through it. It is adhesive, and only requires 24 hours to completely cure, although sternal stability is achieved even sooner. In human cadaver studies, sternal edges adhered together with Kryptonite could not be broken after 2 hours. The proposed benefits of Kryptonite in cardiac surgery patients are the prevention of pathologic sternal displacement, the elimination of regional non-union, the enhancement of functional recovery, and the reduction of sternal wound complications.
The use of Kryptonite to close sternal wounds in cardiac surgery was first described in Calgary, Alberta. This group conducted a small, single-blind randomized clinical trial in 34 patients at low risk for sternal complications (personal communication, Fedak, P). Patients in the Kryptonite group experienced significantly less pain, required less analgesia, and demonstrated a faster return to baseline pulmonary function. The limitations of this study were the small sample size and blinding of patients only. Furthermore, hospital length of stay was not evaluated. A multi-center randomized clinical trial is planned, pending funding.
Objectives: The primary outcome of our trial is quality of life. Secondary endpoints are pain, sternal complications, and respiratory function.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, patients must satisfy ONE of the following criteria:
- •Body mass index (BMI) > 30kg/m2 AND at least one other risk factor. Additional risk factors include insulin dependent diabetes ≥ 5 years, active smoking until time of hospitalization, chronic obstructive pulmonary disease, long-term steroid use equivalent to ≥ 5mgof prednisone daily for > 1 month pre-operatively, alcohol/drug abuse, and mobilization with aid of a walker, cane, scooter, etc.
- •BMI > 40kg/m2
- •Limited mobility with dependence on upper body for mobilization.
排除标准
- •age <18 years
- •cardiac surgery through incision other than sternotomy
- •emergent surgery
- •previous sternotomy (i.e. redo cardiac surgery)
- •surgery for sternal dehiscence or mediastinitis, and
- •inability to obtain informed consent
结局指标
主要结局
Quality of Life
时间窗: Five Weeks
次要结局
- Length of hospital stay(5 weeks)
- pain(5 weeks)
- sternal complications(five weeks)
- respiratory functions(5 weeks)