Botulinum Toxin Injection in the Treatment of Open Abdomen

Open Abdomen Clinical Trial

Official title:

Botulinum Toxin Injection in the Treatment of Open Abdomen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283916
• Other study ID #: 7/2020
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Botulinum Toxin Injection
• Open Abdomen

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