Botulinum Toxin Injection, Open Abdomen
Conditions
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.
Interventions
DRUGBotulinum Toxins
Botulinum toxin injection to abdominal wall
Sponsors
University of Oulu
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open abdomen
Exclusion criteria
* Previous incisional hernia in midline * Patient is not in active treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal wall closure | 30 days | Duration of open abdomen treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 30 days | Time spent in the hospital |
| Hernia | 2 years | Incisional hernia incidence |
| Intensive care time | 30 days | Treatment time in the intensive care unit |
| Enterocutaneus fistula | 30 days | Enterocutaneus fistula incidence |
| Abdominal wall closure success rate | 30 days | the rate of complite abdominal wall closure |
| Re-laparotomies | 30 days | Number of abdominal explorations |
Countries
Finland
Contacts
Primary ContactElisa Mäkäräinen-Uhlbäck, M.D.
Outcome results
None listed