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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