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

Completed

• Conditions: Ventral Hernia

• Registration Number: NCT05610267
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Study Start: 2022-11-22
• Primary Completion: 2022-12-28
• Study Completion: 2022-12-28
• Results First Submitted: 2023-12-18
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Results First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure	90 days	Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure

Secondary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Infections (SSIs) Post Index Procedure	90 days	Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure
Incidence of Later Post-operative Complications After 90 Days Post Index Procedure	1 year	Percentage of subjects with a later post-operative complications after 90 days post index procedure
Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure	90 days	Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure
Incidence of Hernia Recurrence Confirmed by Clinical Assessment	1 year	Percentage of subjects with a hernia recurrence confirmed by clinical assessment
Incidence of Reoperation Requirement Due to Index Repair	1 year	Percentage of subjects with a reoperation requirement due to index repair

Trial Locations

Locations (1)

Surgical Healing Arts Center; 🇺🇸 Fort Myers, Florida, United States