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临床试验/NCT01495962
NCT01495962已完成1 期

The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy: A Pilot Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
46
试验地点
2
主要终点
The primary objective of this study is to determine whether BTX will facilitate primary fascial closure after DCL.

研究概览

简要总结

Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and acute general surgery patients. The technique involves source control of sepsis and hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut short to allow for resuscitation in the ICU after the immediately life threatening pathology is treated. Planned re-exploration is then performed within 24-48 hours. It is at this procedure that the injuries are reconstructed. This technique, unfortunately, has several complications implicit with its use including wound infection, enterocutaneous fistula formation, and intra-abdominal abscess development.[1] Additionally, in patients whom primary fascial closure is not achieved, extensive abdominal wall reconstruction will be required in 6-12 months. The key for preventing these complications is definitive closure of the abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an open abdominal wound at dismissal [1,2] Proven methods for decreasing the rate of planned ventral hernia utilize tension in the midline to counter the effects of lateral abdominal muscular retraction.[3,4,5] Despite these improvements, however, the planned ventral hernia rate continues to be substantial.[2] Botulinum toxin a (BTX) is an FDA approved neuron modulating agent which has been used extensively in cosmetic, motor and pain disorders over the past 20 years [6,7]. The toxin blocks acetylcholine and pain modulator release (calcitonin gene related peptide and substance P) from the pre-synaptic cholinergic nerve terminal. The peptides are unable to bind at their motor end plate receptors through a process that cleaves proteins involved in the transport protein cascade. This results in flaccid paralysis and neuromodulation of the abdominal wall muscles resulting in reduced lateral tension and pain. Theoretically, this could increase the rates of primary fascial closure, improve pain sensation, decrease the rate of complications associated with open abdomens all while lowering the costs and need for future abdominal wall reconstruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Botulinum Toxin A injection

Active Comparator

干预措施: Botulinum Toxin Type A (Drug)

Placebo (Normal Saline) injection

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

The primary objective of this study is to determine whether BTX will facilitate primary fascial closure after DCL.

时间窗: 2 years

The primary endpoint is the rate of delayed primary fascial closure. Delayed primary fascial closure will be considered when the rectus abdominus fascia is directly approximated in the midline during the same hospitalization as the initial DCL without the use of mesh.

次要结局

  • Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry)(2 years)
  • Mortality(2 years)
  • Duration of mechanical ventilation(2 years)
  • Complications (wound infection, fascial dehiscence, enterocutaneous fistula formation, acute renal failure, pneumonia)(2 years)
  • Overall hospital cost(2 years)
  • Total narcotic use (morphine equivalents)(2 years)
  • ABPS score(2 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin D. Zielinski

Assistant Professor of Surgery

Mayo Clinic

研究点 (2)

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