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CompletedNCT01495962Updated Apr 27, 2016

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

A Phase 1 interventional study of Botulinum Toxin Type A and Placebo in Wound; Abdomen, Abdominal Wall, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-27.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Wound; Abdomen, Abdominal Wall

Keywords

  • Damage Control Laparotomy
  • Open Abdomen
  • Botulinum Toxin A
  • Primary Fascial Closure
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 46 is above the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Botulinum Toxin A injection

    Drug: Botulinum Toxin Type A

  • Placebo comparator
    Placebo (Normal Saline) injection

    Drug: Placebo

Interventions

  • DrugBotulinum Toxin Type A

    Six 25 cc injection of Botulinum Toxin A

  • DrugPlacebo

    Placebo (Normal Saline)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. Non-invasive biomechanical testing results (surface wave elastography, traction index and durometry)

    Time frame: 2 years

  2. Mortality

    Time frame: 2 years

  3. Duration of mechanical ventilation

    Time frame: 2 years

  4. Complications (wound infection, fascial dehiscence, enterocutaneous fistula formation, acute renal failure, pneumonia)

    Time frame: 2 years

  5. Overall hospital cost

    Time frame: 2 years

  6. Total narcotic use (morphine equivalents)

    Time frame: 2 years

  7. ABPS score

    Time frame: 2 years

07

Study locations

2 sites
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
  • Regions Hosptial
    St. Paul, Minnesota 55101, United States
08

References and documents

Publications

  • Zielinski MD, Kuntz M, Zhang X, Zagar AE, Khasawneh MA, Zendejas B, Polites SF, Ferrara M, Harmsen WS, Ballman KS, Park MS, Schiller HJ, Dries D, Jenkins DH. Botulinum toxin A-induced paralysis of the lateral abdominal wall after damage-control laparotomy: A multi-institutional, prospective, randomized, placebo-controlled pilot study. J Trauma Acute Care Surg. 2016 Feb;80(2):237-42. doi: 10.1097/TA.0000000000000917. PubMed 26813298 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01495962
Lead sponsor
Mayo Clinic
Responsible party
Martin D. Zielinski (Assistant Professor of Surgery, Mayo Clinic) — Principal investigator
First posted
Dec 20, 2011
Start date
Nov 2011
Primary completion
Aug 2014
Completion
Jun 2015
Last update
Apr 27, 2016

Study contacts

Martin D Zielinski, M.D.
principal investigator · Mayo Clinic
David Dries, MD
principal investigator · Regions Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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