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

NCT05610267 | Completed Results FDA Device

• 1 other identifier: T-GENVIH-002
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of 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

  90 days

• Incidence of Later Post-operative Complications After 90 Days Post Index Procedure

  1 year

• Incidence of Hernia Recurrence Confirmed by Clinical Assessment

  1 year

• Incidence of Reoperation Requirement Due to Index Repair

  1 year

Other Outcomes (2)

• Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)

  90 days

• Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled

  90 days

Interventions

Retrospective chart review DEVICE

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).

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)..
• Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.

You may not qualify if:

• Subject has known allergy to porcine-derived products.
• 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.
• Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
• Subject had uncontrolled diabetes, defined as Hb1AC value \>7% within 12 weeks prior to index procedure.
• Subject has been diagnosed with cirrhosis and/or ascites.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

Surgical Healing Arts Center

Fort Myers, Florida, 33912, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Dennis Adam Young
• Organization: Integra LifeSciences

dennis.young@integralife.com

443 766 2569

Study Officials

• Adam Young, MD

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: November 22, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)