NCT00665730终止不适用
Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)
Genzyme, a Sanofi Company6 个研究点 分布在 5 个国家目标入组 5 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
研究概览
简要总结
This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.
排除标准
- •Patients who are pregnant.
- •Patients with ongoing abdominal abscess.
- •Patients with ongoing bacterial peritonitis.
结局指标
主要结局
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
时间窗: 8-14 weeks
次要结局
- Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.(8-14 weeks)
- Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.(8-14 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.Adhesion PreventionNCT00813397Genzyme, a Sanofi Company210
终止
不适用
Evaluation of the Safety of Sepraspray in Open Abdominal SurgeryAdhesion Prevention (Abdominal)NCT00778479Genzyme, a Sanofi Company155
Unknown
3 期
SUPRACOR for Myopia and Myopic AstigmatismMyopic AstigmatismMyopiaPresbyopiaNCT01404884Technolas Perfect Vision GmbH60
终止
1 期
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and PsychotherapyDepressive Disorder, MajorNCT04951609Janssen Research & Development, LLC31
已完成
不适用
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General SurgeryDigestive System Surgical ProceduresIntestinal ObstructionNCT00130715Genzyme, a Sanofi Company