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.

NCT06556030 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BOTU-CLOSURE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 (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.

Conditions

Botulinum Toxin Type A; Open Abdomen; Abdominal Wall; Clinical Trial

Keywords

botulinum toxin, open abdomen, laparostomy, abdominal wall closure, clinical trial.

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days

Study Arms (2)

Control

PLACEBO COMPARATOR

physiological saline 50 cc

Other: CONTROL

botulinum toxin

EXPERIMENTAL

Intramuscular injection into the flat muscles of the abdominal wall of 300/500 Units of botulinum toxin A dissolved in 100 cc of physiological saline, distributed in 5 points on each side of the abdomen in the first 48 hours after leaving the abdomen open.

Drug: Botulinum Toxin A

Interventions

Botulinum Toxin A DRUG

Botulinum Toxin

botulinum toxin

CONTROL OTHER

Saline Solution

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. Subjects able and willing to participate and to be followed for most of the duration of the study.

You may not qualify if:

• 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.
• \. Drugs that affect muscle tone or the autonomic nervous system, e.g. administration of antibiotics such as aminoglycosides, lincosamides, polymyxins or tetracyclines.
• \. Pregnancy or lactation. 4. Known hypersensitivity. 5. Active neoplastic disease.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Victor Vaello Jodra, Consultant

  Hospital Universitario del Henares

  PRINCIPAL INVESTIGATOR

• Luis Asensio Gomez, Consultant

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Vaello Jodra, Consultant

CONTACT

0034 696550460; botuclosure@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-05