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

Wound; Abdomen, Abdominal Wall Clinical Trial

Official title:

The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495962
• Other study ID #: 10-008404
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2011
• Last updated: April 25, 2016
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Injuries
• Wound; Abdomen, Abdominal Wall

Intervention

Drug:
• Botulinum Toxin Type A
Six 25 cc injection of Botulinum Toxin A
• Placebo
Placebo (Normal Saline)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Regions Hosptial	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine whether BTX will facilitate primary fascial closure after DCL.	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.	2 years	No
Secondary	Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry)		2 years	No
Secondary	Mortality		2 years	No
Secondary	Duration of mechanical ventilation		2 years	No
Secondary	Complications (wound infection, fascial dehiscence, enterocutaneous fistula formation, acute renal failure, pneumonia)		2 years	No
Secondary	Overall hospital cost		2 years	No
Secondary	Total narcotic use (morphine equivalents)		2 years	No
Secondary	ABPS score		2 years	No