Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Botulinum Toxin A Injection for Patients with Large Incisional Hernia

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the treatment of a condition known as incisional hernia. An incisional hernia occurs when tissue pushes through a weak spot in the abdominal wall, often at the site of a previous surgical incision. The study is investigating the use of a treatment called botulinum toxin A, specifically a product named XEOMIN, which is a type of protein that can help relax muscles. The purpose of the study is to see if injecting botulinum toxin A into the muscles of the abdominal wall before surgery can reduce complications after the surgical repair of large incisional hernias.

Participants in the study will receive either the botulinum toxin A injection or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who receives the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The trial will follow participants through their surgery and recovery, monitoring for any complications and measuring various outcomes over a period of time, including up to one year after surgery.

The study aims to gather information on the effectiveness of botulinum toxin A in reducing the rate of complications after hernia repair surgery. It will also look at other factors such as the length of hospital stay, the severity of any complications, and the overall recovery process. By comparing the results between those who receive the treatment and those who receive the placebo, researchers hope to determine if botulinum toxin A can improve surgical outcomes for patients with large incisional hernias.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, body mass index, and the characteristics of the hernia.

    Written informed consent is required to participate.

  2. Step 2

    Preoperative preparation

    A botulinum toxin A injection is administered into the lateral abdominal wall muscles. This is done to potentially reduce complications after surgery.

    The injection is given as an intramuscular injection using a solution prepared from XEOMIN 100 units or a placebo.

  3. Step 3

    Surgical procedure

    Surgery is scheduled for the repair of the incisional hernia using a mesh.

    The procedure aims to repair hernias that are at least 10 cm wide.

  4. Step 4

    Postoperative monitoring

    During the 90-day period after surgery, monitoring for complications is conducted. This includes checking for any issues classified as grade II or higher according to the Clavien-Dindo classification.

    The length of the hospital stay is recorded, and the severity of any complications is assessed.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are conducted at various intervals: 1 month, 3 months (90 days), 6 months, and 12 months after surgery.

    These assessments include measuring pain levels, checking for any recurrence of the hernia, and evaluating the quality of life using the EQ-5D-5L scale.

Who can join the trial?

7 criteria

  • Patients must be between 18 and 79 years old.
  • Patients should have a BMI (Body Mass Index) of less than 35 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
  • Patients must have a midline anterior primary or recurrent incisional hernia (a type of hernia that occurs along a previous surgical incision) that is at least 10 cm wide, as seen on a CT scan of the abdomen and pelvis done within the last 6 months.
  • The hernia should not have a loss of domain, which means the hernia should not take up more than 25% of the space inside the abdomen, as shown on a CT scan done within the last 6 months.
  • Patients must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
  • Patients should be scheduled for an open surgery to repair the incisional hernia.
  • Women who can have children must use highly effective birth control methods.

Who cannot join the trial?

9 criteria

  • Patients who are under 18 years old or over 65 years old cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with a history of severe allergic reactions to medications or treatments cannot join.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are excluded.
  • Patients who have had a major surgery in the last 3 months are not allowed to participate.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients who are currently participating in another clinical trial cannot join this study.
  • Patients with a known infection or active cancer are not eligible.
  • Patients who are unable to follow the study procedures or attend follow-up visits are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Botulinum Toxin A: This medication is used in the trial to relax the muscles of the abdominal wall before surgery. The goal is to reduce complications after the surgical repair of a large incisional hernia. By injecting this toxin into the muscles, it is expected to make the surgery easier and improve recovery.

What is already known about the treatment

Botulinum Toxin A – This medication is administered through an injection into the lateral abdominal wall muscles. It is currently being studied in clinical trials for its potential to improve surgical outcomes in patients with large incisional hernias. The main therapeutic indication is to reduce postoperative complications following hernia repair surgery. At the molecular level, Botulinum Toxin A works by blocking the release of a neurotransmitter called acetylcholine, which leads to muscle relaxation. It is classified as a neuromuscular blocking agent.

Investigated diseases

Incisional Hernia – An incisional hernia occurs when tissue protrudes through a surgical wound that has not healed properly. It often develops at the site of a previous surgical incision in the abdominal wall. The hernia may become noticeable as a bulge under the skin, especially when straining or lifting heavy objects. Over time, the hernia can increase in size and may cause discomfort or pain. If left untreated, it can lead to complications such as bowel obstruction or strangulation. The progression of the hernia depends on factors like the size of the defect and the physical activity of the individual.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504554-35-00Protocol codeAPHP220805Estimated enrolment260 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.