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Clinical trial to evaluate the efficacy of early administration of botulinum toxin in open abdominal closure.
EU CTIS ID: 2025-522410-23-00
What this study is testing
To demonstrate the efficacy of botulinum toxin in the primary midline closure of patients with an open abdomen compared to placebo within 20 days.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects capable of understanding the study's purpose and risks, providing written informed consent and authorising the use of confidential health information in accordance with applicable regulations.
- If the patient cannot provide consent due to an emergency status, consent will be obtained from a first- or second-degree relative. If the patient regains decision-making capacity, consent will be requested to continue participation.
- Patients aged 18 years or older at the time of inclusion.
- Patients who have undergone abdominal surgery resulting in an open abdomen per clinical practice, in whom administration of the investigational treatment is feasible within 48 hours after the procedure that led to the open abdomen.
- Subjects willing and able to participate and comply with study procedures and follow-up visits for most of the study duration.
You likely can't join if
- Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Presence of conditions potentially interfering or worsening with botulinum toxin use (e.g., hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
- Known hypersensitivity to botulinum toxin.
- Active neoplastic disease.
- Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- Any condition or situation which, in the opinion of the investigator, may interfere with the efficacy and/or safety evaluation of the trial.
See the full eligibility criteria
- Subjects capable of understanding the study's purpose and risks, providing written informed consent and authorising the use of confidential health information in accordance with applicable regulations.
- If the patient cannot provide consent due to an emergency status, consent will be obtained from a first- or second-degree relative. If the patient regains decision-making capacity, consent will be requested to continue participation.
- Patients aged 18 years or older at the time of inclusion.
- Patients who have undergone abdominal surgery resulting in an open abdomen per clinical practice, in whom administration of the investigational treatment is feasible within 48 hours after the procedure that led to the open abdomen.
- Subjects willing and able to participate and comply with study procedures and follow-up visits for most of the study duration.
- Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Presence of conditions potentially interfering or worsening with botulinum toxin use (e.g., hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
- Known hypersensitivity to botulinum toxin.
- Active neoplastic disease.
- Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- Any condition or situation which, in the opinion of the investigator, may interfere with the efficacy and/or safety evaluation of the trial.
- Patients with severe uncorrected coagulopathy or bleeding disorders (prolonged bleeding times) that, in the opinion of the investigator, contraindicate intramuscular injections.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.