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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Retrospective chart review

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Surgical Healing Arts Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)	Number of days between the date of the index procedure and the date of the hospital discharge	90 days
Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled	Number of subjects who used opioids following the procedure based on the concomitants medication	90 days

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Adam Young, MD, Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: T-GENVIH-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes