A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
研究概览
简要总结
Primary Objectives
- To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
- To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
- To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
- To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
- To compare the length of hospital stay between the two groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
干预措施: EVICEL (Drug)
Evicel
For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
干预措施: EVICEL (Drug)
结局指标
主要结局
To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
时间窗: 90 days
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
次要结局
未报告次要终点
研究者
Shaun A. Nguyen
Associate Professor - Director of Clinical Research
Medical University of South Carolina