A multicentre, randomised, single-blind, controlled protocol to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with open abdomen. Early use (less than 48 hours) of botulinum toxin as a neuromuscular abdominal wall blocker in patients whose abdomen is left open, regardless of the cause, will improve postoperative outcome and prognosis, leading to significantly higher percentages of primary midline closure.
1. Subjects must be able to understand the purpose and risks of the study, giving informed consent and authorising the use of confidential health information. If the patient is unable to consent due to emergency status, a first or second degree relative will be requested. If the patient recovers, the patient's consent to continue participation will be sought again.
Personal historyDiseases which, in the opinion of the investigator, may interfere with or worsen the action of the botulinum toxin. For example, patients with: hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton Lamber syndrome or ALS are excluded.
Parallel
Botulinum Toxin A
DrugBotulinum Toxin
CONTROL
Other interventionSaline Solution
Main Endpoint
Percentage of patients achieving primary midline closure in the experimental group compared to the control group (within 20 days after the first procedure where the abdomen is left open).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
