Post-market Study of the Biodesign Hernia Graft

Overview

The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Full Title of Study: “Post-market Study of the Biodesign® Hernia Graft”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2026

Detailed Description

This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair. This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site. This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.

Interventions

  • Device: Biodesign Hernia Graft
    • The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.

Clinical Trial Outcome Measures

Primary Measures

  • Hernia recurrence
    • Time Frame: 1-year
    • Hernia recurrence through 1-year follow-up

Secondary Measures

  • Device-, procedure-, and hernia-related adverse event rates
    • Time Frame: 2-year
    • Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates)
  • Hernia recurrence rate through 2-year follow-up
    • Time Frame: 2-year
    • Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up
  • Operative times
    • Time Frame: 2-year
    • What was the operation time for the ventral hernia repair?
  • Hospital stay
    • Time Frame: 2-year
    • Duration of hospital stay
  • Hospitalization times for related Serious Adverse Events (SAEs)
    • Time Frame: 2-year
    • What was the hospitalization times for any related SAEs?
  • Patient-reported quality of life: questionaire
    • Time Frame: 2-year
    • Patient-reported quality of life assessed by completion of a questionaire

Participating in This Clinical Trial

Inclusion Criteria

1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft Exclusion Criteria:

1. Known sensitivity to porcine material For the study, the following patients will also be excluded: 2. Age < 18 years 3. Unable or unwilling to provide informed consent 4. Life expectancy of less than one year from the date of the index procedure 5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cook Biotech Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Samantha Stevenson, BS, 765-497-3385, sstevenson@cookbiotech.com

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