Clinical trial to evaluate the efficacy of early administration of botulinum toxin in open abdominal closure.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario La Paz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2026-03-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate the efficacy of botulinum toxin in the primary midline closure of patients with an open abdomen compared to placebo within 20 days.

Secondary objectives 7

1. To evaluate de safety of botulinum toxin in the primary midline closure of patients with an open abdomen.
2. To evaluate if botulinum toxin reduces the duration the abdomen remains open.
3. To evaluate the efficacy of botulinum toxin in reducing the incidence of midline continuity defects.
4. To evaluate if the time from toxin injection to closure influences the success rate of the closure.
5. To evaluate the impact of botulinum toxin on the respiratory status of critically ill patients with an open abdomen.
6. To evaluate the impact of botulinum toxin on the quality of life of patients.
7. To evaluate the impact of early open abdomen closure on surgical site infection.

Conditions and MedDRA coding

open abdomen

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. 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.
3. Patients aged 18 years or older at the time of inclusion.
4. 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.
5. Subjects willing and able to participate and comply with study procedures and follow-up visits for most of the study duration.

Exclusion criteria 7

1. Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
2. Presence of conditions potentially interfering or worsening with botulinum toxin use (e.g., hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
3. Known hypersensitivity to botulinum toxin.
4. Active neoplastic disease.
5. Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
6. Any condition or situation which, in the opinion of the investigator, may interfere with the efficacy and/or safety evaluation of the trial.
7. Patients with severe uncorrected coagulopathy or bleeding disorders (prolonged bleeding times) that, in the opinion of the investigator, contraindicate intramuscular injections.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion (%) of patients achieving approximation of the middle fascial edges with sutures, regardless of adjunctive measures (e.g. traction sutures or temporary meshes), provided that definitive bridging with a permanent mesh is not used.

Secondary endpoints 7

1. Incidence of treatment-emergent adverse events potentially related to botulinum toxin (e.g., clinically relevant muscle weakness, injection-site reactions), serious adverse events, and all-cause mortality through day 30.
2. Time (in days) from the open-abdomen procedure to primary midline fascial closure or to planned ventral hernia is established (not total midline closure but skin closure).
3. Incidence of midline continuity defect (incisional hernia) confirmed by physical examination and/or imaging at 6 months.
4. Mean number of patients achieving the primary objective with botulinum toxin administration within the first 24 hours compared to those administered between 24 and 48 hours.
5. Incidence of respiratory complications (distress, atelectasis, prolonged intubation, reintubation within 72 hours or oxygen requirements) during acute hospitalization.
6. SF-36 questionnaire results at 1 and 6-month follow-up.
7. Incidence of surgical site infections based on the day of midline closure since the open abdomen, measured over 30 days without mesh and 90 days with mesh.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario La Paz

Sponsor organisation

Hospital Universitario La Paz

Address

Paseo De La Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Hospital Universitario La Paz

Contact name

Luis Asensio Gómez

Public contact point

Organisation

Hospital Universitario La Paz

Contact name

Luis Asensio Gómez

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications