188
Participants
Start Date
November 1, 2025
Primary Completion Date
December 15, 2027
Study Completion Date
December 15, 2029
OnabotulinumtoxinA Injection
A total of 300 units of onabotulinumtoxinA will be reconstituted 150 cc of injectable 0.9% NaCl (for a final concentration of 2 units / cc). Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites (six injection sites total per patient). At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.
Saline (placebo) Injection
150 cc of injectable 0.9% NaCl will be prepared. Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites. At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.
OnabotulinumtoxinA
"300 units of onabotulinumtoxinA will be prepared and administered as described in: Procedure/Surgery: OnabotulinumtoxinA Injections"
0.9 % Normal Saline
"150cc of normal saline will be prepared and administered as described in: Procedure/Surgery: Saline (placebo) Injection."
Open Ventral Hernia Repair
Open abdominal wall reconstruction will be conducted in our standard fashion for the repair of very large hernias. The surgery is the same for patients who are not in the study. Surgeons will be blinded to the study arm of participant patients.
Joseph and Florence Mandel Family Foundation
UNKNOWN
The Cleveland Clinic
OTHER