CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Incisional hernia

Inclusion criteria

• {"criterion_text":"- Patients between 18 and 79 years\n- BMI < 35 kg/m²\n- Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width >= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3)\n- IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) < 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion\n- Written informed consent\n- Scheduled surgery for an open IH repair\n- For female of childbearing potential: using highly effective contraception"}

Exclusion criteria

• {"criterion_text":"- Other types of IH (lateral, groin, para-stomal, port-site) are allowed, provided they are not the target of surgical treatment (i.e., not intended to be repaired as part of the current intervention)\n- Ongoing skin infection or inflammation at the IH site or at the BTA injection site\n- Planned IH repair with slowly absorbable mesh\n- IH with loss of domain (volumetric ratio > 25%)\n- Emergency IH surgery\n- ASA score > 3\n- Pregnancy or breastfeeding\n- Ongoing treatment with aminoglycosides\n- Patient with ongoing treatment with medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. tubocurarine-type muscle relaxants that weaken the muscles\n- Patient with severe and uncontrolled cardiovascular diseases\n- Patient has received BTA within 12 weeks\n- Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant\n- Patients with a history of seizures\n- Active tobacco use (or cessation inferior to 3 months)\n- Use of another investigational product within 6 months or 5 half-lives (whichever is longer), or currently participating in a prospective study with an investigational product, whether it concerns an experimental drug or a medical device\n- Patient not covered by social insurance\n- Patient under legal guardianship\n- Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose)\n- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy), facial nerve disorders, underlying neurological disorders) and history of dysphagia and aspiration)\n- VHWG grades 3 or 4 for the risk of surgical site infection"}

Primary endpoints

• {"endpoint_text":"- Occurrence of Clavien-Dindo classification grade II or higher post-operative complication during the 90-day postoperative period.","definition_or_measurement_approach":"Occurrence of post-operative complications classified as Clavien-Dindo grade II or higher occurring within the 90-day postoperative period."}

Secondary endpoints

• {"endpoint_text":"- Length of hospital stay in days","definition_or_measurement_approach":"Measured as number of days of hospitalisation following surgery."}
• {"endpoint_text":"- Severity of complication according to the Clavien-Dindo classification during the 90-day postoperative period","definition_or_measurement_approach":"Complication severity graded by the Clavien-Dindo classification within 90 days postoperatively."}
• {"endpoint_text":"- Occurrence of CST during IH repair, Occurrence of incomplete wall closure (bridge closure) during IH repair","definition_or_measurement_approach":"Recorded intraoperative events: whether component separation technique (CST) was used and whether wall closure was incomplete (bridge repair) during the indexed IH repair."}
• {"endpoint_text":"- Sum of the length variation of the left and right lateral muscles (cm), sum of the width variation of the left and right lateral muscles (cm), sum of the width (cm) and surface (cm²) variation of the muscular defect; peritoneal sac volume (cm3) variation, between the pre-inclusion CT and the CT 4 weeks after BTA injection","definition_or_measurement_approach":"Radiological measurements on non-contrast abdominal CT at baseline and 4 weeks after injection comparing changes in lateral muscle length/width, defect width and area, and peritoneal sac volume."}
• {"endpoint_text":"- Intravesical pressure, measured daily until bladder catheter removal","definition_or_measurement_approach":"Daily intravesical pressure measurements recorded until urinary catheter removal."}
• {"endpoint_text":"- Pain on Analogical Visual Scale at inclusion, from 1st to 7th postoperative day and at 1, 3 (90 days), 6, and 12 months after surgery ; 90-day postoperative prescription of type 3 analgesics","definition_or_measurement_approach":"Patient-reported pain using the Visual Analog Scale at specified timepoints and tracking prescription/use of type 3 analgesics during first 90 days."}
• {"endpoint_text":"- Occurrence of post-operative abdominal wall disruption during a 90 days period after surgery; occurrence of clinical recurrence of the IH during the first year after surgery; occurrence of radiological recurrence of the IH at 12 months post-surgery; 1-year postoperative occurrence of clinical and radiological recurrence of the IH, or reoperation for recurrence;","definition_or_measurement_approach":"Clinical and radiological assessment for abdominal wall disruption and hernia recurrence up to 1 year post-surgery; record of reoperations for recurrence."}
• {"endpoint_text":"- EQ-5D-5L at inclusion, 90 days, 6, and 12 months after surgery","definition_or_measurement_approach":"Health-related quality of life measured using the EQ-5D-5L instrument at specified timepoints."}

France

Earliest CTIS Part Ii Submission Date

29-03-2024

Latest Decision Or Authorization Date

13-11-2025

Processing Time Days

594

Number Of Sites

18

Number Of Participants

260

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Programme Hospitalier de Recherche Clinique - PHRC 2021 (French Ministry of Health)","duties_or_roles":"Monetary support","organisation_type":""}