The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495962
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic

November 15, 2011
December 20, 2011
April 27, 2016
November 2011
August 2014   (Final data collection date for primary outcome measure)
The primary objective of this study is to determine whether BTX will facilitate primary fascial closure after DCL. [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01495962 on Archive Site
  • Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry) [ Time Frame: 2 years ]
  • Mortality [ Time Frame: 2 years ]
  • Duration of mechanical ventilation [ Time Frame: 2 years ]
  • Complications (wound infection, fascial dehiscence, enterocutaneous fistula formation, acute renal failure, pneumonia) [ Time Frame: 2 years ]
  • Overall hospital cost [ Time Frame: 2 years ]
  • Total narcotic use (morphine equivalents) [ Time Frame: 2 years ]
  • ABPS score [ Time Frame: 2 years ]
Same as current
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The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy
The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy: A Pilot Study
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.
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Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Wound; Abdomen, Abdominal Wall
  • Drug: Botulinum Toxin Type A
    Six 25 cc injection of Botulinum Toxin A
  • Drug: Placebo
    Placebo (Normal Saline)
  • Active Comparator: Botulinum Toxin A injection
    Intervention: Drug: Botulinum Toxin Type A
  • Placebo Comparator: Placebo (Normal Saline) injection
    Intervention: Drug: Placebo
Zielinski MD, Kuntz M, Zhang X, Zagar AE, Khasawneh MA, Zendejas B, Polites SF, Ferrara M, Harmsen WS, Ballman KS, Park MS, Schiller HJ, Dries D, Jenkins DH. Botulinum toxin A-induced paralysis of the lateral abdominal wall after damage-control laparotomy: A multi-institutional, prospective, randomized, placebo-controlled pilot study. J Trauma Acute Care Surg. 2016 Feb;80(2):237-42. doi: 10.1097/TA.0000000000000917.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2015
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • male or female, aged ≥ 18 years or older
  • signed Informed Consent form by appropriate patient representative
  • undergone a DCL for trauma or acute general surgery

Exclusion Criteria

  • death prior to BTX injection
  • failure to achieve hemodynamic stability within 24 hours (stable or decreasing vasopressor support within 6 hours in combination with a stable or improving base deficit or lactate level)
  • Viable pregnancy
  • At risk populations (<18 years of age, prisoners)
  • BMI > 50
  • Pre-existing pareses (Amyotrophic Lateral Sclerosis, myopathies, motor polyneuropathies
  • impaired neuromuscular transmission (Myasthenia Gravis, Lambert-Eaton Syndrome)
  • concurrent aminoglycoside use
  • chronic obstructive pulmonary disease
  • known metastatic malignancy
  • pre-existing cirrhosis
  • necrotizing fasciitis of the trunk
  • hypocoagulable state (INR >1.5)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Martin D. Zielinski, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Martin D Zielinski, M.D. Mayo Clinic
Principal Investigator: David Dries, MD Regions Hospital
Mayo Clinic
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP