Ventral Hernia
Conditions
Brief summary
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.
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
DEVICEBiodesign 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.
Sponsors
Cook Biotech Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence | 1-year | Hernia recurrence through 1-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-, Procedure-, and Hernia-related Adverse Event Rates | 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 | 2-year | Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up |
| Operative Times | During operation | What was the operation time for the ventral hernia repair for patients who had a follow-up at least 1 month after procedure. |
| Hospital Stays for Serious Adverse Events | 2-year | Number of patients with serious adverse events that required a hospital stay |
| Hospitalization Times for Related Serious Adverse Events (SAEs) | From date of hospitalization for SAE. Patients were followed up to 2 years. | Hospitalization times for patients with related Serious Adverse Events (SAEs). For patients who were followed up to 2 years after procedure. |
| Patient-reported Quality of Life: Yes/No | 2-year | Patient-reported quality of life assessed by completion of a questionaire |
| Patient Reported Quality of Life-Pain Questions | 2-year follow-up | Patient reported quality of life related to pain |
| Patient Reported Quality of Life-abdominal Wall | 2-year follow-up | patient reported quality of life related to abdominal wall |
Countries
Canada, United States
Participant flow
Pre-assignment details
21 patients that were consented failed the screen.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 10.7 |
| Number of patients with hernia | 47 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 46 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 14 / 47 |
| serious Total, serious adverse events | 10 / 47 |
Outcome results
None listed