Resorbable Mesh for Ventral Hernia (RECOVER Trial)

N/A

Recruiting

Research Sponsored by Medtronic - MITG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is 18 years of age or older at the time of consent

Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new type of resorbable mesh called Transorb™ in patients at high risk for wound healing issues during hernia repair surgeries. The study will evaluate its effectiveness and safety in

Who is the study for?

This trial is for adults over 18 with a high risk of complications in wound healing, undergoing elective open repair of ventral hernia. Eligible participants include current or former heavy smokers, those with obesity (BMI between 30 and 39.9), and individuals with COPD. The surgery must involve retrorectus/retromuscular mesh placement, possibly including TAR.

What is being tested?

The RECOVER study tests the performance and safety of Transorb™ Self-Gripping Resorbable Mesh in reinforcing abdominal wall tissues during ventral hernia repair surgeries that are clean or clean-contaminated as per CDC guidelines.

What are the potential side effects?

While specific side effects aren't listed here, generally such surgical meshes may cause discomfort, inflammation at the site, infection risks, potential allergic reactions to materials used in the mesh or issues related to improper healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a specific surgery to repair a hernia in my abdomen using a special technique.

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My wound is clean and not infected, according to CDC standards.

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I have smoked (or used to smoke) at least 20 packs of cigarettes a year.

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I have been diagnosed with COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months for reporting.