NCT00576745已完成1 期
Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of erythema
研究概览
简要总结
Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing mediastinotomy for cardiac surgical procedures
排除标准
- •Patients with:
- •Allergies to skin adhesives
- •Known keloid formation
- •Prior sternotomies
- •Conditions making them not candidates for vicryl skin closure
研究组 & 干预措施
1 Vicryl Suture
Active Comparator
Patients will have their incision closed with vicryl suture
干预措施: Vicryl Suture (Procedure)
2 Steri-Strips
Experimental
Patients will have their incisions closed with 3M Surgical-Strips
干预措施: 3M TM S Surgical Skin Closure System (Device)
结局指标
主要结局
Incidence of erythema
时间窗: 30 days following surgery
次要结局
- Incidence of infection(30 days following surgery)
研究者
Harold L. Lazar MD
Professor of Cardiothoracic Surgery
Boston Medical Center
研究点 (1)
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