Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Severity of Adhesions at the Retrosternal Site
研究概览
简要总结
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an acceptable surrogate capable of giving consent on the subject's behalf.
- •Pediatric patients ages 0 - 17
- •Have a cardiac disease which requires staged cardiac surgery and resternotomy
- •Non-emergent state or emergent state with sufficient time to educate and consent
排除标准
- •An immune system disorder
- •Unplanned reoperation
- •Known hypersensitivity to components in CoSeal
- •Patients undergoing reoperation less than 3 months after the primary surgery
结局指标
主要结局
Severity of Adhesions at the Retrosternal Site
时间窗: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Diaphragm Site
时间窗: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Post-operative Bleeding
时间窗: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Post-operative bleeding through surgical site drainage output.
Adhesion Burden
时间窗: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)
Skin to bypass time as an indicator of adhesion burden.
Severity of Adhesions at the Arterial Base Site.
时间窗: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Left Lateral Site
时间窗: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Right Lateral Site
时间窗: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
次要结局
- Hospital Stay(Length of stay after second surgery up to 1 month)
研究者
Nahidh Hasaniya
Associate Professor
Loma Linda University