Botulinum Toxin Injection in the Treatment of Open Abdomen

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.

Study Overview

• Status: Recruiting
• Conditions: Open Abdomen; Botulinum Toxin Injection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Elisa Mäkäräinen-Uhlbäck, M.D.; Phone Number: +358505794011; Email: elisa.makarainen-uhlback@ppshp.fi

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Elisa Makarainen-Uhlback; Phone Number: +35883152282

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 consecutive open abdomen patients

Description

Inclusion Criteria:

• Open abdomen

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal wall closure	Duration of open abdomen treatment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care time	Treatment time in the intensive care unit	30 days
Hospitalization	Time spent in the hospital	30 days
Hernia	Incisional hernia incidence	2 years
Re-laparotomies	Number of abdominal explorations	30 days
Enterocutaneus fistula	Enterocutaneus fistula incidence	30 days
Abdominal wall closure success rate	the rate of complite abdominal wall closure	30 days

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 7/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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