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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01495962
First received: November 15, 2011
Last updated: February 12, 2014
Last verified: February 2014

November 15, 2011
February 12, 2014
November 2011
June 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Complications (wound infection, fascial dehiscence, enterocutaneous fistula formation, acute renal failure, pneumonia) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall hospital cost [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Total narcotic use (morphine equivalents) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • ABPS score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Damage Control Laparotomy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2014
June 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)
Both
18 Years and older
No
Contact: Martin D Zielinski, M.D. 507-255-2923 Zielinski.martin@mayo.edu
United States
 
NCT01495962
10-008404
No
Martin D. Zielinski, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Martin D Zielinski, M.D. Mayo Clinic
Mayo Clinic
February 2014

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