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

This study has been completed.
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic Identifier:
First received: November 15, 2011
Last updated: April 25, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Wound; Abdomen, Abdominal Wall
Drug: Botulinum Toxin Type A
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum Toxin A injection Drug: Botulinum Toxin Type A
Six 25 cc injection of Botulinum Toxin A
Placebo Comparator: Placebo (Normal Saline) injection Drug: Placebo
Placebo (Normal Saline)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01495962

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Regions Hosptial
St. Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Martin D Zielinski, M.D. Mayo Clinic
Principal Investigator: David Dries, MD Regions Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Martin D. Zielinski, Assistant Professor of Surgery, Mayo Clinic Identifier: NCT01495962     History of Changes
Other Study ID Numbers: 10-008404
Study First Received: November 15, 2011
Last Updated: April 25, 2016

Keywords provided by Mayo Clinic:
Damage Control Laparotomy
Open Abdomen
Botulinum Toxin A
Primary Fascial Closure

Additional relevant MeSH terms:
Abdominal Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents processed this record on April 24, 2017