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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04283916
Other study ID # 7/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 21, 2020
Est. completion date August 2024

Study information

Verified date January 2024
Source University of Oulu
Contact Elisa Mäkäräinen-Uhlbäck, M.D.
Phone +358505794011
Email elisa.makarainen-uhlback@ppshp.fi
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Open abdomen Exclusion Criteria: - Previous incisional hernia in midline - Patient is not in active treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum Toxins
Botulinum toxin injection to abdominal wall

Locations

Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (1)

Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal wall closure Duration of open abdomen treatment 30 days
Secondary Intensive care time Treatment time in the intensive care unit 30 days
Secondary Hospitalization Time spent in the hospital 30 days
Secondary Hernia Incisional hernia incidence 2 years
Secondary Re-laparotomies Number of abdominal explorations 30 days
Secondary Enterocutaneus fistula Enterocutaneus fistula incidence 30 days
Secondary Abdominal wall closure success rate the rate of complite abdominal wall closure 30 days
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