Botulinum Toxin Injection in the Treatment of Open Abdomen
- Conditions
- Botulinum Toxin InjectionOpen Abdomen
- Interventions
- Drug: Botulinum Toxins
- Registration Number
- NCT04283916
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Open abdomen
- Previous incisional hernia in midline
- Patient is not in active treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Botox injection Botulinum Toxins 30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation.
- Primary Outcome Measures
Name Time Method Abdominal wall closure 30 days Duration of open abdomen treatment
- Secondary Outcome Measures
Name Time Method Hospitalization 30 days Time spent in the hospital
Hernia 2 years Incisional hernia incidence
Enterocutaneus fistula 30 days Enterocutaneus fistula incidence
Re-laparotomies 30 days Number of abdominal explorations
Intensive care time 30 days Treatment time in the intensive care unit
Abdominal wall closure success rate 30 days the rate of complite abdominal wall closure
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland