NCT05610267

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

A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Retrospective chart review	The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).

Timeline

• Start date: 2022-11-22
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2022-11-09
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study