Preoperative BOTOX® Injection for Large Ventral Hernia Repair

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07220382
Phase
PHASE4
Status
Recruiting
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Conditions

  • Botox Injection
  • Hernia
  • Hernia Abdominal Wall
  • Hernia Incisional
  • Hernia Incisional Ventral
  • Hernia Repair With Compartment Syndrome
  • Hernia Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OnabotulinumtoxinA Injection — PROCEDURE
    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 — PROCEDURE
    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 — DRUG
    300 units of onabotulinumtoxinA will be prepared and administered as described in: "Procedure/Surgery: OnabotulinumtoxinA Injections"
  • 0.9 % Normal Saline — DRUG
    150cc of normal saline will be prepared and administered as described in: "Procedure/Surgery: Saline (placebo) Injection".
  • Open Ventral Hernia Repair — PROCEDURE
    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.

Study Details

This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as "BOTOX®" (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall fully at the end of the operation. Closing the muscle and tissue layers ("primary fascial closure") is linked to fewer problems after surgery and better quality of life. Participants will be randomly assigned (like a coin flip) to receive either the BOTOX® medicine or a saltwater (placebo) injection. Neither patients nor the care team will know which one was given. All participants will still have their planned hernia repair in the standard way that we repair patients who are not part of the study. The study will track whether the abdomen can be closed without leaving a gap, and investigators will also look at recovery, complications, time in the ICU or on a ventilator, length of stay, pain, and quality-of-life scores. Most information will be collected during participants' hospital stay, but the investigators will continue to see how participants are doing up to 2 years after surgery. Short phone check-ins will occur before surgery, and after surgery follow-up happens around 30 days, 90 days, 1 year, and 2 years. Possible risks from the injection include temporary muscle weakness, trouble swallowing or breathing, pain or infection at the injection site, and (if CT is used for guidance) a small amount of radiation exposure. Surgery itself carries the usual risks (pain, bleeding, wound problems). Benefits are not guaranteed, but the injection may make closure easier and recovery smoother. About 188 people will take part at Cleveland Clinic.

Key Dates

Start date
Nov 3, 2025
Status verified
Nov 2025
Primary completion
Dec 15, 2027
Completion
Dec 15, 2029

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OnabotulinumtoxinA Group
    These patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.
  • Placebo Comparator: Placebo Group
    These patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.

Primary Outcome Measure

Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon) [ Time Frame: This will be measured (recorded) on the day of the hernia repair surgery, which will be 21 to 48 days after receiving your BOTOX injection. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44195
Lucas R Beffa, MD
[email protected]
216-445-5975
William C Bennett, MD
[email protected]
216-313-8971
Lucas R Beffa, MD (PRINCIPAL_INVESTIGATOR)
Clayton C Petro, MD (SUB_INVESTIGATOR)
Benjamin T Miller, MD (SUB_INVESTIGATOR)
Ajita S Prabhu, MD (SUB_INVESTIGATOR)
David M Krpata, MD (SUB_INVESTIGATOR)
Luciano G Tastaldi, MD (SUB_INVESTIGATOR)

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Cleveland Clinic Main Campus· Cleveland, OH

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