drugset / Trial / NCT06556030

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

Phase 4 Not yet recruiting 50 enrolled Instituto de Investigación Hospital Universitario La Paz
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-01
Primary completion
2026-06
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 300 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 500 iu Intramuscular