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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495962
First Posted: December 20, 2011
Last Update Posted: April 27, 2016
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.
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic
  Purpose
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 (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 Martin D. Zielinski, 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)

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495962


Locations
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin D. Zielinski, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01495962     History of Changes
Other Study ID Numbers: 10-008404
First Submitted: November 15, 2011
First Posted: December 20, 2011
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Martin D. Zielinski, Mayo Clinic:
Damage Control Laparotomy
Open Abdomen
Botulinum Toxin A
Primary Fascial Closure

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


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