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New treatment option for Hernia Abdominal Wall
Official title Preoperative BOTOX® Injection for Large Ventral Hernia Repair
ClinicalTrials.gov ID: NCT07220382
What this study is testing
What is OnabotulinumtoxinA?
OnabotulinumtoxinA is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hernia abdominal wall.
Also referred to as BOTOX®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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%
You likely can't join 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...
- Known congenital or acquired neuromuscular disorder
- Presence of stoma
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.