Botulinum toxin type A - haemagglutinin complex for Open abdomen

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients aged 18 years or older at the time of inclusion."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects willing and able to participate and comply with study procedures and follow-up visits for most of the study duration."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion (%) of patients achieving approximation of the middle fascial edges with sutures; outcome assessed by clinical/surgical evaluation of fascial edge approximation, independent of adjunctive measures, excluding cases with definitive bridging using a permanent mesh."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Incidence (count and proportion) of treatment-emergent adverse events, serious adverse events, and all-cause mortality up to day 30; events categorized as potentially related to botulinum toxin (examples provided)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Time-to-event measured in days from open-abdomen procedure to primary midline fascial closure or establishment of planned ventral hernia (skin closure), recorded as days."}
• {"endpoint_text":"- Incidence of midline continuity defect (incisional hernia) confirmed by physical examination and/or imaging at 6 months.","definition_or_measurement_approach":"Incidence (proportion) of incisional hernia confirmed by physical exam and/or imaging at 6 months post-procedure."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Comparison (mean/summary) of numbers/proportions of patients achieving the primary objective when toxin is administered within 0–24 hours versus 24–48 hours."}
• {"endpoint_text":"- Incidence of respiratory complications (distress, atelectasis, prolonged intubation, reintubation within 72 hours or oxygen requirements) during acute hospitalization.","definition_or_measurement_approach":"Incidence (proportion) of specified respiratory complications during acute hospitalization, including distress, atelectasis, prolonged intubation, reintubation within 72 hours, or requirement for oxygen."}
• {"endpoint_text":"- SF-36 questionnaire results at 1 and 6-month follow-up.","definition_or_measurement_approach":"SF-36 health survey scores collected at 1 and 6 months; results summarized by domain and overall scores."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Incidence (proportion) of surgical site infections stratified by day of midline closure; measured over 30-day follow-up when no mesh used and 90-day follow-up when mesh used."}

Spain

Earliest CTIS Part Ii Submission Date

19-02-2026

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

13

Number Of Sites

5

Number Of Participants

30

Primary sponsor

Full Name

Hospital Universitario La Paz

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain