Preoperative BOTOX® Injection for Large Ventral Hernia Repair

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

December 15, 2027

Study Completion Date

December 15, 2029

Conditions
Hernia Abdominal WallBotox InjectionHernia Incisional VentralHernia Repair With Compartment SyndromeHernia SurgeryHerniaHernia Incisional
Interventions
PROCEDURE

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.

PROCEDURE

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.

DRUG

OnabotulinumtoxinA

"300 units of onabotulinumtoxinA will be prepared and administered as described in: Procedure/Surgery: OnabotulinumtoxinA Injections"

DRUG

0.9 % Normal Saline

"150cc of normal saline will be prepared and administered as described in: Procedure/Surgery: Saline (placebo) Injection."

PROCEDURE

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.

All Listed Sponsors
collaborator

Joseph and Florence Mandel Family Foundation

UNKNOWN

lead

The Cleveland Clinic

OTHER