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 study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States. Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will be followed for approximately 3 months after surgery and will receive a follow-up phone call 30 days (+/-) their last study visit. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Injection; intramuscular
Placebo
Injection; intramuscular
Injection; intramuscular
NYU Langone Hospital - Long Island /ID# 251280
Mineola, New York, United States
Atrium Health Carolinas Medical Center /ID# 247711
Charlotte, North Carolina, United States
Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair
PFC will be defined as the ability to achieve fascia to fascia midline approximation. CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Time frame: Up to 4 Months
Percentage of participants with achievement of PFC
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Time frame: Up to 4 Months
Percentage of participants with usage of CST for the purpose of PFC
CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Time frame: Up to 4 Months
Number of lateral abdominal wall muscles released among participants who required CST use to achieve PFC as reported by the operating surgeon
Lateral abdominal wall muscles are released by TAR and external oblique release (unilateral or bilateral)
Time frame: Up to 4 Months
Change in length of lateral abdominal wall complex
Change in length of lateral abdominal wall complex as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Time frame: Up to 4 Months
Change in Width to the Hernia Defect
Change from screening in width to the hernia defect as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Time frame: Up to 4 Months
Change from screening in length of lateral abdominal wall complex
Change from screening in length of lateral abdominal wall complex as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair will be assessed.
Time frame: Up to 4 Months
Change from screening in width to the hernia defect
Change from screening in width to the hernia defect as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair
Time frame: Up to 4 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.