About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Botulinum Toxin A
- CONTROL