Back to search results

BOTOX® Injections Before Large Ventral Hernia Repair

This study is for adults with very large abdominal hernias who are planning to have open surgery to fix them. It's looking at whether a single injection of BOTOX® (onabotulinumtoxinA) into the abdominal muscles, given 3-7 weeks before surgery, helps surgeons fully close the abdominal wall during the operation. A full closure of the muscle and tissue layers (called "primary fascial closure") is important for better recovery and fewer problems. You would be randomly assigned to receive either the BOTOX® injection or a saltwater (placebo) injection. Neither you nor your care team would know which one you received. The study aims to enroll 188 participants, but its current status is unclear.

Study design
This is a randomized, double-blind study, meaning you'll be assigned by chance to one of two groups, and neither you nor your doctors will know which treatment you receive. It plans to enroll 188 participants.
What's involved
You would receive an injection (either BOTOX® or saline) 21 to 48 days before your planned hernia repair surgery. The hernia repair surgery itself would be conducted as standard.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at the end of your hernia repair surgery, which is 21 to 48 days after your injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220382

Preoperative BOTOX® Injection for Large Ventral Hernia Repair

Recruiting
PHASE4Ages 18+InterventionalTreatment
The Cleveland Clinic
~188 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:OnabotulinumtoxinA InjectionSaline (placebo) InjectionOnabotulinumtoxinA0.9 % Normal SalineOpen Ventral Hernia Repair

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon)
Measured over 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.

Conditions

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

Explore related trials

Ventral Hernia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Lucas R Beffa, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Lucas R Beffa, MD
[email protected]
216-445-5975
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adult (greater than or equal to 18 years of age)
Candidate for elective open repair of ventral hernia
Preoperative imaging demonstrating either:
ventral hernia defect width of at lest 15 cm; AND/OR,
Tanaka volume ratio of at least 25%
Planned elective hernia repair in an open fashion via a midline laparotomy with posterior component separation and transversus abdominis release

Exclusion

Emergent cases
Pregnancy and/or breastfeeding at time of intramuscular injection
Inability to provide informed consent
Inability to receive either study intervention (i.e. allergy to local anesthetics utilized for intervention administration, allergy and/or contraindication to any botulinum toxin, inability to attend outpatient administration of study intervention, inability to conform to safety check schedule)
Known congenital or acquired neuromuscular disorder
Presence of stoma
Current infection at time of intramuscular injection
Flank hernias s defined by EHS L1-L4
BMI \> 45 kg/m\^2
Diaphragmatic hemiparesis or chronic obstructive pulmonary disease (COPD) with chronic oxygen dependence

What this trial measures

  • Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon)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.

    Primary fascial closure (PFC) is the successful closure of the hernia. It will be defined in a binary, categorical manner as: "Yes" (fascial closed) or "No" (fascia not closed and bridging mesh required). To be considered "Yes" for PFC, the midline anterior fascia must be completely re-approximated via absorbable running or figure-of-eight sutures. If any segment of the anterior fascia cannot be approximated and closed, the patient will require anterior bridging and this would be considered a failure of PFC. Surgeons will decide if the fascia can be closed or if it cannot be closed by their expertise and discretion. No prespecified criteria have been established which dictate operative decision-making. The study team will record an outcome of "Yes" for PFC if the fascia is successfully closed by the surgeon via an eligible technique as previously described.