Using Botulinum Toxin A to Improve Surgery for Large Incisional Hernias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Botulinum Toxin A (BTA) injections to facilitate the surgical repair of large incisional hernias, which are challenging to treat due to muscle retraction and separation. The study compares outcomes between patients receiving BTA and those receiving a placebo, aiming to reduce postoperative morbidity and improve surgical closure success. By inducing temporary muscle paralysis, BTA may help relax the abdominal muscles, making it easier to close the hernia without complex surgical techniques. The trial includes patients aged 18 to 79 with specific criteria related to hernia size and type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients between 18 and 79 years;
2. BMI \< 35 kg/m²;
3. 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);
4. 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;
5. Written informed consent;
6. Scheduled surgery for an open IH repair;
7. For female of childbearing potential: using highly effective contraception.

Exclusion Criteria:

1. Other types of IH (lateral, groin, para-stomal, portsite);
2. VHWG grades 3 or 4 for the risk of surgical site infection;
3. Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
4. Planned IH repair with slowly absorbable mesh;
5. IH with loss of domain (volumetric ratio \> 25%);
6. Emergency IH surgery;
7. ASA score \> 3;
8. Pregnancy or breastfeeding;
9. Ongoing treatment with aminoglycosides;
10. Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;
11. Active tobacco use (or cessation inferior to 3 months);
12. 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;
13. Patient not covered by social insurance;
14. Patient under legal guardianship;
15. Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose);
16. 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);
17. 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;
18. Patient with severe and uncontrolled cardiovascular diseases;
19. Patient has received BTA within 12 weeks;
20. Patients with a history of seizures.

Where it's running

• David Moszkowicz
  Colombes, France, France Recruiting

Study contacts

• Principal investigator: David MOSZKOWICZ — Aphp
• Study coordinator: David MOSZKOWICZ, MD-PhD
• Email: david.moszkowicz@aphp.fr
• Phone: +33 (0)1 47 60 66 02

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific biomechanical modeling of incisional hernias with AI and finite element analysis

  Researchers will test a personalized computer model of the abdominal wall for adults with incisional hernias using anonymized CT data and AI to see how the hernia shapes relate to tissue mechanics.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07898449

• Risk factors for mesh infection after abdominal wall reconstruction

  This study tests which factors put adults at risk for mesh infection after abdominal wall reconstruction using different mesh types.

  Recruiting Minia University · Minya, Minya Governorate · NCT07725718

• Hernia Sac Flap Coverage of Mesh in Complex Bony-Edged Ventral Hernias

  We’re testing whether using the patient’s own hernia sac as a living flap underneath the mesh helps healing after complex ventral hernia repair when part of the edge is bone.

  Recruiting Minia University · Minya, Minya Governorate · NCT07720154

• No abdominal incision in minimally invasive colorectal surgery: a multicenter registry of natural orifice specimen extraction

  This registry follows adults having minimally invasive colorectal surgery to compare outcomes when the specimen is removed through a natural opening versus through an abdominal incision.

  Recruiting Singapore General Hospital · Singapore · NCT07615036

• Does pre-surgery physical activity predict complications after incisional hernia repair?

  We will test whether adults' activity levels before incisional hernia surgery predict their risk of complications afterward.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07192978

• Negative pressure dressings after emergency midline laparotomy

  This trial will test whether using negative pressure wound therapy on adults having emergency midline laparotomy lowers wound complications compared with standard dressings.

  Recruiting at 5 sites Uppsala University · Eskilstuna and 5 other locations · NCT07003906

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.