NCT02196519已完成不适用
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Number of Adverse Events
研究概览
简要总结
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age
- •Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
- •Be scheduled for an ileostomy reversal procedure
- •Be willing to follow instructions for incision care
- •Agree to return for all follow-up evaluations specified in this protocol
- •Sign informed consent
排除标准
- •Anesthesia risk judged to be higher than ASA2
- •Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- •Any condition involving compromised immune system
- •Any condition known to effect wound healing, such as collagen vascular disease
- •Known blood clotting disorder
- •Be receiving antibiotic therapy for pre-existing condition or infection
- •Concurrent use of fibrin sealants or other anastomosis care devices
- •Be currently taking systemic steroids or immunosuppressive agents
- •Have known or suspected allergy or sensitivity to any test materials or reagents
- •Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
研究组 & 干预措施
Test
Experimental
All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.
干预措施: Sylys Surgical Sealant (Device)
结局指标
主要结局
Number of Adverse Events
时间窗: 30 days
次要结局
未报告次要终点
研究者
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