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Botulinum Toxin A for Large Incisional Hernia Repair
NCT06499324Phase 3
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- incisional hernia
01
Overview
Phase 3, randomised, double-blind trial in incisional hernia comparing BTA group with Placebo group (2 arms). Primary endpoint: Rate of postoperative morbimortality at 90 days. Started Jan 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BTA group
Injection of 288 IU of Xeomin
Placebo group
Injection of Placebo
03
Who it enrols
Adult patients (18-79 years) with midline anterior primary or recurrent incisional hernia (width >= 10 cm) scheduled for open repair with mesh. Excludes patients with BMI >= 35, loss of domain > 25%, emergency surgery, ASA > 3, active tobacco use, or contraindications to BTA.
04
Endpoints
Primary
Rate of postoperative morbimortality
Secondary
Length of hospital stay
Severity of surgical complications
Surgical difficulty (CST, incomplete closure)
Radiological response: lateral muscles elongation
Radiological response: muscular defect reduction
Radiological response: hernia sac volume
Intra-abdominal pressure
Pain evolution and consumption of analgesics
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