Integrated Mesh-Fascial Closure for Incisional Hernia Repair

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 prospective, non-randomized study compares two abdominal wall closure techniques in adults with incisional or ventral hernias and planned mesh use. One group uses the standard fascial closure with mesh fixed separately, while the other uses Integrated Mesh-Fascial Closure (IMFC), weaving a macroporous mesh into the fascial suture. Participants choose their group after informed consent and are followed for 18 to 24 months with clinical assessments and imaging to assess safety, feasibility, and recurrence. The study is conducted at a single center in Argentina and aims to standardize IMFC and compare outcomes to standard closure. Background data indicate incisional hernia is common and recurrence after mesh repair can be substantial, motivating this comparative evaluation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults older than 18 years of age
* Patients with incisional (ventral) hernia
* Patients with recurrent incisional hernia
* Incisional hernias with a diameter greater than 4 cm
* Patients undergoing laparotomy with an indication for prophylactic mesh placement

Exclusion Criteria:

* Active surgical site infection
* Overt abdominal contamination
* Tissue necrosis or inability to achieve primary fascial closure
* Non-correctable loss of domain
* Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
* Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines
* Active oncologic disease (patients with a cured oncologic history may be included)

Where it's running

• Hospital Zonal General de Agudos "Dr. Mario V. Larrain
  Berisso, Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Facundo B Mattano, MD — Hospital Zonal General de Agudos "Dr. Mario V. Larrain
• Study coordinator: Facundo B Mattano, MD
• Email: mattanofacundo@outlook.com
• Phone: +54 9 221 611-7976

Similar studies

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

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• Minimally invasive laparoscopic and robotic repair for non-inguinal abdominal wall hernias

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• Pre-surgery BOTOX to help close very large ventral hernias

  This test tries a one-time image-guided BOTOX injection into the side abdominal muscles 3–7 weeks before open repair to see if it helps surgeons fully close very large ventral hernias in adults.

  Recruiting Phase 4 The Cleveland Clinic · Cleveland, Ohio · NCT07220382

• 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

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.