95
Participants
Start Date
November 10, 2020
Primary Completion Date
December 31, 2026
Study Completion Date
June 30, 2027
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.
RECRUITING
Vanderbilt University Medical Center, Nashville
RECRUITING
St. Paul's Hospital, Vancouver
RECRUITING
Queen Elizabeth II Hospital, Halifax
Lead Sponsor
Cook Biotech Incorporated
INDUSTRY