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Botulinum Toxin Injection in the Treatment of Open Abdomen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04283916
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
Elisa Makarainen-Uhlback, University of Oulu

Brief Summary:
Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.

Condition or disease Intervention/treatment
Open Abdomen Botulinum Toxin Injection Drug: Botulinum Toxins

Detailed Description:
30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Botulinum Toxin Injection in the Treatment of Open Abdomen
Actual Study Start Date : February 21, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022

Group/Cohort Intervention/treatment
Botox injection
30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation.
Drug: Botulinum Toxins
Botulinum toxin injection to abdominal wall

Primary Outcome Measures :
  1. Abdominal wall closure [ Time Frame: 30 days ]
    Duration of open abdomen treatment

Secondary Outcome Measures :
  1. Intensive care time [ Time Frame: 30 days ]
    Treatment time in the intensive care unit

  2. Hospitalization [ Time Frame: 30 days ]
    Time spent in the hospital

  3. Hernia [ Time Frame: 2 years ]
    Incisional hernia incidence

  4. Re-laparotomies [ Time Frame: 30 days ]
    Number of abdominal explorations

  5. Enterocutaneus fistula [ Time Frame: 30 days ]
    Enterocutaneus fistula incidence

  6. Abdominal wall closure success rate [ Time Frame: 30 days ]
    the rate of complite abdominal wall closure

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 consecutive open abdomen patients

Inclusion Criteria:

  • Open abdomen

Exclusion Criteria:

  • Previous incisional hernia in midline
  • Patient is not in active treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04283916

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Contact: Elisa Mäkäräinen-Uhlbäck, M.D. +358505794011

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Oulu University Hospital Recruiting
Oulu, Finland
Contact: Elisa Makarainen-Uhlback    +35883152282      
Sponsors and Collaborators
University of Oulu
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Responsible Party: Elisa Makarainen-Uhlback, Principal Investigator, University of Oulu Identifier: NCT04283916    
Other Study ID Numbers: 7/2020
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs