Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Botulinum Toxin Type A
Open Abdomen
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 (l...
Detailed Description
According to the definition of the World Society for Emergency Surgery (WSES), an open abdomen is defined as the intentional creation of a laparostomy by non-approximation of the aponeurotic edges of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06556030
Start Date
January 1 2025
End Date
December 1 2026
Last Update
August 15 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.