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Completed

NCT Number: NCT05610267

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.

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Key information

Conditions

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

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Healing Arts Center

Fort Myers, Florida, 33912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure

    Time frame: 90 days

    Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure

Secondary outcomes

  1. Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure

    Time frame: 90 days

    Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure

  2. Incidence of Surgical Site Infections (SSIs) Post Index Procedure

    Time frame: 90 days

    Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure

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

    Time frame: 1 year

    Percentage of subjects with a later post-operative complications after 90 days post index procedure

  4. Incidence of Hernia Recurrence Confirmed by Clinical Assessment

    Time frame: 1 year

    Percentage of subjects with a hernia recurrence confirmed by clinical assessment

  5. Incidence of Reoperation Requirement Due to Index Repair

    Time frame: 1 year

    Percentage of subjects with a reoperation requirement due to index repair

Other outcomes

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

    Time frame: 90 days

    Number of days between the date of the index procedure and the date of the hospital discharge

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

    Time frame: 90 days

    Number of subjects who used opioids following the procedure based on the concomitants medication

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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