Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

Integra LifeSciences

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Retrospective chart review

Study type: Observational

Funder types: Industry

Identifiers

NCT05610267

T-GENVIH-002

Details and patient eligibility

About

The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.

Full description

Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.

Enrollment: 28 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
2. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.

Exclusion criteria

1. Subject has known allergy to porcine-derived products.
2. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
3. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
4. Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.
5. Subject has been diagnosed with cirrhosis and/or ascites.

Trial design