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First received: November 01, 2022

Clinical Trial: A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Ventral Hernia

Study Type: INTERVENTIONAL


Official Title: A Phase 2b Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA for the Achievement of Primary Fascial Closure Without the Use of

Brief Summary: Ventral hernias form when there is a loss of integrity of the abdominal wall muscles.Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens.The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without use of component separation technique (CST) in ventral hernia surgical repair.BOTOX is an investigational drug being developed for the treatment of ventral hernias.In this dose escalation…

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