Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 2
- 主要终点
- Haemostatic effect
研究概览
简要总结
This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.
详细描述
A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was conducted from May 17th, 2020 until October 20th, 2021 (current status: completed). This study assessed the efficacy of Sternum GuardTM, a commercially-available nonwoven cellulose based, single use, sterile surgical drape used for covering the dissected sternal bone edge during median sternotomy for cardiac surgery. The active comparator/ control group in this study is the use of Bone wax, a vaseline and beeswax-made materials widely used during sternotomy as a mean of bleeding control. The subjects were adults undergoing elective cardiac surgery with median sternotomy approach for any indication. Both the patients and the principal investigators were blinded for the treatment-control allocation, but the surgeon were not blinded for the materials used. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative. The minimum sample size was 414 subjects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects/participants were not aware of the arms/treatment given as they were under general anesthesia during the application of interventions being studied. Besides, during the informed consent for the elective sternotomy procedure, subjects were extensively given explanation of the purpose, methods, benefits and risks of the procedure including the randomized nature of the allocation to either arms of the study.
Principal investigators as well as outcomes assessor were kept unaware of the randomization of interventions as they both were restricted for assessing the patients' medical record and the patient identity were coded in the primary database.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages > 18 years old
- •Patients who are scheduled electively for cardiac surgery
- •Cardiac surgery with the usage of cardiopulmonary bypass machine
- •Patients who are agreed to participate in this study
排除标准
- •Patients who are scheduled for surgery in emergency or urgent manner
- •Patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus.
- •Patients with the history of past cardiac surgery
- •Drop - out Criteria:
- •Patients who are pronounced death on operation table
- •Patients who are pronounced death within hospitalization
- •Patients who are lost to follow up (Day 30 post-operative)
- •Patients who are not committed for the whole stage of the research
结局指标
主要结局
Haemostatic effect
时间窗: immediately after the median sternotomy surgery finished
It will assess the quantity of blood lost from the sternal edges in Sternum GuardTM and Bone Wax group. The Sternum GuardTM and sterile drapes will be weighed before and after surgery to estimate the blood lost.
Satisfaction rate
时间窗: within 24 hours after surgery
A rating value from the surgeon as the user of the materials being investigated in terms of satisfaction upon the performance and practicality of the either materials from surgeon's personal opinion.
Surgical site infection
时间窗: within 30 days after the sternotomy surgery performed
A surgical site infection is an infection occurring within 30 days after the operation and only involving the skin and subcutaneous tissue (superficial) or involving deep soft tissues (fibrous connective tissues and muscle layers) of the post-surgical incision wounds. Superficial surgical site infections is identified by at least one of the following: purulent drainage, organisms isolated from an aseptically-obtained culture of fluid or tissue from the surgical site, presence of signs or symptoms of infection: pain or tenderness, localised swelling, redness or heat, or diagnosis of SSI by the surgeon or attending physician. A deep incisional SSI is an infection appears to be related to the operative procedure and involves deep soft tissues which is indicated by either; purulent drainage, a deep incision spontaneously dehisces, an abscess, diagnosis of a deep incisional SSI by a surgeon or attending physician.
次要结局
未报告次要终点
研究者
Dudy Arman Hanafy, Sp. BTKV (K), MARS
Principal Investigator
Fakultas Kedokteran Universitas Indonesia