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A study to evaluate the use of botulinum toxin type A - haemagglutinin complex to help close the abdomen in patients with an open abdomen.

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What is this trial about?

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

This study focuses on patients with an open abdomen, a condition where the abdominal wall is left open after surgery instead of being closed immediately. The purpose of the study is to evaluate whether early administration of botulinum toxin type a - haemagglutinin complex helps in the primary midline closure, which is the process of bringing the edges of the muscle layers together during surgery. This medication, also known as DYSPORT, is given through an intramuscular injection, which is a shot delivered directly into the muscle.

During the study, participants will receive either the study medication or a placebo. The process involves observing how well the abdominal muscles can be stitched together within a specific timeframe. Researchers will monitor for various factors, such as the time it takes for the muscle layers to close and the possibility of developing an incisional hernia, which is a protrusion of tissue through the surgical site. The study also tracks potential side effects, such as muscle weakness or reactions at the site of the injection, as well as respiratory issues or infections at the surgery location.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment administration</b>

    An intramuscular injection, which is a needle injected into the muscle, is administered. this injection contains botulinum toxin type a - haemagglutinin complex, known as dysport, at a dose of 500 units.

    This step occurs either within the first 24 hours or between 24 and 48 hours after the initial procedure for the open abdomen (a condition where the abdominal wall is left open).

  2. Step 2

    <b>clinical monitoring and follow-up</b>

    During the hospitalization, monitoring is conducted for respiratory complications, such as breathing difficulties or the need for oxygen.

    The progress of the midline closure, which refers to the closing of the middle part of the abdominal wall, is observed to see if the edges of the muscle layer can be brought together with sutures (stitches) within 20 days.

    The presence of adverse events, such as muscle weakness or reactions at the site of the injection, is tracked through day 30.

    surgical site infections are monitored for 30 days if no mesh is used, or for 90 days if a mesh is used.

  3. Step 3

    <b>long-term evaluation</b>

    At 1 month and 6 months after the procedure, a sf-36 questionnaire is completed to assess health status.

    At 6 months, a physical examination or imaging is performed to check for the occurrence of an incisional hernia, which is a gap or bulge at the site of the surgical scar.

Who can join the trial?

7 criteria

  • You must be at least 18 years old at the start of the study.
  • You must have an open abdomen, which means your abdominal cavity (the area containing your stomach and organs) was left open during surgery instead of being closed with skin or stitches.
  • You must be able to receive the investigational treatment (the experimental medicine being tested) within 48 hours after the surgery that left your abdomen open.
  • You must be able to understand the reasons and risks of the study and provide written informed consent, which is a signed document showing you agree to participate after being told all the details.
  • If you are unable to provide consent because of a medical emergency, a close family member may provide permission for you.
  • If a family member provides permission, you must be able to give your own consent to continue once you are well enough to make decisions again.
  • You must be willing and able to follow all the study procedures and attend all scheduled follow-up visits (check-up appointments) for the duration of the study.

Who cannot join the trial?

7 criteria

  • You are not willing or able to follow the scheduled appointments, the treatment plan, the laboratory tests, or the lifestyle rules required for the study.
  • You have conditions that might interfere with or make the use of botulinum toxin (the medicine being tested) worse, such as hyperthyroidism (an overactive thyroid gland), neuromuscular disease (disorders that affect how nerves and muscles work together), myasthenia gravis (a disease that causes muscle weakness), Eaton-Lambert syndrome (a rare condition that affects the connection between nerves and muscles), or amyotrophic lateral sclerosis (a disease that affects the nerve cells in the brain and spinal cord).
  • You have a known hypersensitivity (an allergic reaction) to botulinum toxin.
  • You have an active neoplastic disease (an ongoing cancer).
  • You are pregnant (carrying a developing baby) or breastfeeding.
  • You have any other health issue that the doctor believes could stop the study from safely or correctly measuring how well the medicine works.
  • You have severe uncorrected coagulopathy or bleeding disorders (conditions where your blood does not clot properly, leading to longer bleeding times) that make it unsafe for the doctor to give you an injection into a muscle.
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Investigated drugs

Botulinum toxin is an injection used in this study to help relax the muscles of the abdominal wall. The goal is to see if using this medication can help the abdominal wound close more easily and quickly in patients who have had surgery leaving the abdomen open.

What is already known about the treatment

Dysport - This medication is a powder that is mixed into a liquid and given through a direct injection into the muscle. Currently used in many medical treatments, it works by blocking the signals that tell muscles to contract, which helps to relax them at a molecular level. It belongs to a class of drugs known as neurotoxins and is primarily used to treat various conditions involving excessive muscle activity or tension.

Investigated diseases

Open abdomen - This condition occurs when the abdominal wall is left open and cannot be immediately closed during surgery. It is often a temporary state where the internal organs are protected by a covering rather than being contained within the skin and muscle layers. Over time, the muscles and tissues may become tense or swollen, which can make it difficult to bring the edges of the abdominal wall together. The progression involves managing the exposed organs until the layers of the abdomen can be safely reapplied.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522410-23-00Protocol codePilot BOTU-CLOSUREEstimated enrolment30 patientsSponsorHospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

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