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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610267
• Other study ID #: T-GENVIH-002
• Status: Completed
• Start date: November 22, 2022
• Est. completion date: December 28, 2022

Study information

• Verified date: June 2024
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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).

Locations

Country	Name	City	State
United States	Surgical Healing Arts Center	Fort Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	Incidence of Surgical Site Infections (SSIs) Post Index Procedure	Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure	90 days
Secondary	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
Secondary	Incidence of Hernia Recurrence Confirmed by Clinical Assessment	Percentage of subjects with a hernia recurrence confirmed by clinical assessment	1 year
Secondary	Incidence of Reoperation Requirement Due to Index Repair	Percentage of subjects with a reoperation requirement due to index repair	1 year