Trial record 13 of 171 for:    Open Studies | botulinum toxin

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
  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
Damage Control Laparotomy
Drug: Botulinum Toxin Type A
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495962

Contacts
Contact: Martin D Zielinski, M.D. 507-255-2923 Zielinski.martin@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Melissa M Kuntz    507-293-1239    kuntz.melissa@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Martin D Zielinski, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Martin D. Zielinski, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01495962     History of Changes
Other Study ID Numbers: 10-008404
Study First Received: November 15, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014