Preoperative BOTOX® Injection for Large Ventral Hernia Repair

NCT07220382 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 25-824
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

BOTOX; Ventral Hernia; Abdominal Wall Reconstruction; OnabotulinumtoxinA; Preoperative BOTOX; Primary Fascial Closure; Fascial Bridging; Transversus Abdominis Release; Posterior Component Separation

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Secondary Outcomes (42)

• 30-Day Surgical Site Occurrence (SSO) - Proportion of Participants (%)

  Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

• 30-Day Surgical Site Infection (SSI) - Proportion of Participants (%)

  Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

• 30-Day SSOPI (Surgical Site Occurrence Requiring Procedural Intervention) - Proportion of Participants (%)

  Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

• 30-Day Readmission - Proportion of Participants (%)

  Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

• 30-Day Reoperation - Proportion of Participants (%)

  Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

Other Outcomes (14)

• Fascial Tension (Pre-Release and Post-Component Separation) - Force Units (lbs)

  During hernia repair surgery

• Plateau Airway Pressure - cmH₂O

  During hernia repair surgery and one day after surgery (if still requiring mechanical ventilation post-operatively)

• Change in Plateau Pressure With Closure - cmH₂O

  During hernia repair surgery

Study Arms (2)

OnabotulinumtoxinA Group

EXPERIMENTAL

These patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.

Procedure: OnabotulinumtoxinA Injection; Drug: OnabotulinumtoxinA; Procedure: Open Ventral Hernia Repair

Placebo Group

PLACEBO COMPARATOR

These patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.

Procedure: Saline (placebo) Injection; Drug: 0.9 % Normal Saline; Procedure: Open Ventral Hernia Repair

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.

Also known as: BOTOX® Injection

OnabotulinumtoxinA Group

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.

Placebo Group

OnabotulinumtoxinA DRUG

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

Also known as: BOTOX®

OnabotulinumtoxinA Group

0.9 % Normal Saline DRUG

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

Also known as: Saline, Salt Water, Placebo, Normal Saline, NaCl

Placebo Group

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.

Also known as: Abdominal Wall Reconstruction, Posterior Component Separation

OnabotulinumtoxinA Group; Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Joseph and Florence Mandel Family Foundation: collaborator

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Abdominal; Hernia; Incisional Hernia; Hernia, Ventral

Interventions

Botulinum Toxins, Type A; Sodium Chloride; Injections; Saline Solution; Fluoridation; Abdominoplasty

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health; Cosmetic Techniques; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Lucas R Beffa, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas R Beffa, MD

CONTACT

216-445-5975; beffal@ccf.org

William C Bennett, MD, MS

CONTACT

216-445-9989; bennetw2@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the intervention drug (botulinumtoxin vs placebo). Radiologist(s) performing the injection will be blinded to the intervention drug. Surgeon(s) performing the hernia repair will be blinded to the intervention drug. Only study personnel and pharmacists who are not participating in a patient's surgery will know the randomization group (intervention or placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 23, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)