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NCT07220382 · ClinicalTrials.gov registry record · Phase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
A Phase 4 study of Hernia and Hernia Abdominal Wall, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 188
- Enrollment target
- 1
- Study location
NCT07220382 is a Phase 4 study of Hernia and Hernia Abdominal Wall that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 188 participants, roughly in line with the 186-participant average among 11 other Hernia trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT07220382, a Phase 4 study of Hernia and Hernia Abdominal Wall, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 188 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG OnabotulinumtoxinA
- PROCEDURE OnabotulinumtoxinA Injection
- PROCEDURE Saline (placebo) Injection
- DRUG 0.9 % Normal Saline
- PROCEDURE Open Ventral Hernia Repair
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2025-11-03 |
| Est. Completion | 2029-12-15 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07220382
The ClinicalTrials.gov registry entry for NCT07220382 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 186-participant average among 11 other Hernia trials with a reported enrollment target. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Hernia appearing as the primary indexed condition, and to 5 interventions - of which OnabotulinumtoxinA is the first listed.
NCT07220382 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT07220382 about?
NCT07220382 is a clinical study titled "Preoperative BOTOX® Injection for Large Ventral Hernia Repair". 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 th...
What is the current status of trial NCT07220382?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 188 participants. The study started on 2025-11-03. Estimated completion is 2029-12-15.
What conditions does trial NCT07220382 study?
This clinical trial studies the following conditions: Hernia, Hernia Abdominal Wall, Hernia Incisional Ventral, Hernia Incisional, Botox Injection.
What interventions are being tested in trial NCT07220382?
The interventions under investigation include: OnabotulinumtoxinA (DRUG), OnabotulinumtoxinA Injection (PROCEDURE), Saline (placebo) Injection (PROCEDURE), 0.9 % Normal Saline (DRUG), Open Ventral Hernia Repair (PROCEDURE).
Who is sponsoring clinical trial NCT07220382?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07220382 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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