Status:
COMPLETED
The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy
Lead Sponsor:
Mayo Clinic
Conditions:
Wound; Abdomen, Abdominal Wall
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 abbrevi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01495962
Start Date
November 1 2011
End Date
June 1 2015
Last Update
April 27 2016
Active Locations (2)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
2
Regions Hosptial
Saint Paul, Minnesota, United States, 55101