Botulinum Toxin Injection in the Treatment of Open Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Abdominal wall closure
研究概览
简要总结
Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.
详细描述
30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Open abdomen
排除标准
- •Previous incisional hernia in midline
- •Patient is not in active treatment
研究组 & 干预措施
Botox injection
30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation.
干预措施: Botulinum Toxins (Drug)
结局指标
主要结局
Abdominal wall closure
时间窗: 30 days
Duration of open abdomen treatment
次要结局
- Hospitalization(30 days)
- Hernia(2 years)
- Enterocutaneus fistula(30 days)
- Re-laparotomies(30 days)
- Intensive care time(30 days)
- Abdominal wall closure success rate(30 days)
研究者
Elisa Mäkäräinen
Principal Investigator
University of Oulu