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.

Launched by INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether an early treatment with botulinum toxin can help patients who have had abdominal surgery and need to keep their abdomen open for healing. The aim is to see if giving this treatment within 48 hours of surgery can improve the chances of successfully closing the abdomen later on. This study will include adults over 18 years old who have undergone surgery that required their abdomen to be left open, regardless of the reason.

To participate, individuals must be able to understand the study and give their consent, or have a family member provide consent if they are unable due to an emergency. However, some people won’t be eligible, such as those with certain medical conditions like neuromuscular diseases or those taking specific medications that could interfere with the treatment. Participants can expect regular follow-ups during the study and will play an important role in helping researchers learn more about the potential benefits of this treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 2. Subjects Patients over 18 years of age who, regardless of the cause, have undergone abdominal surgery, after which it has been necessary to leave the abdomen open.
• • 3. Subjects able and willing to participate and to be followed for most of the duration of the study.
• Exclusion Criteria:
• • 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.
• • 2. Drugs that affect muscle tone or the autonomic nervous system, e.g. administration of antibiotics such as aminoglycosides, lincosamides, polymyxins or tetracyclines.
• • 3. Pregnancy or lactation. 4. Known hypersensitivity. 5. Active neoplastic disease.