The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy
- Conditions
- Wound; Abdomen, Abdominal Wall
- Interventions
- Drug: Placebo
- Registration Number
- NCT01495962
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Botulinum Toxin A injection Botulinum Toxin Type A - Placebo (Normal Saline) injection Placebo -
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine whether BTX will facilitate primary fascial closure after DCL. 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.
- Secondary Outcome Measures
Name Time Method Mortality 2 years Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry) 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
Trial Locations
- Locations (2)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Regions Hosptial
🇺🇸St. Paul, Minnesota, United States