Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)

Completed

Conditions studied: Ventral Incisional Hernia

In brief

The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.

Key facts

Study ID

NCT02129140

Run by

Icahn School of Medicine at Mount Sinai

People needed

30

Starts

2014-04-01

Expected to finish

2019-05-16

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing a ventral incisional hernia repair with mesh
• Age range between 18 and 80 years old

You may not qualify if…

• Patients currently enrolled in a clinical trial.
• Patients with a BMI over 40
• Patients in whom the fascial layers cannot be closed or in whom "bridging" would be used
• Patients with a current abdominal abscess or infection
• Patients with healing disorders
• Pregnant women

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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