Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
Choon Hyuck David Kwon
Summary
The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.
Description
The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults. MiMedx placental tissue grafts are registered with the FDA for homologous use in any location in the body as a protective barrier that supports the healing cascade, which is the use the investigators intend it for in this trial. The main questions this study aims to answer are: 1. Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complica…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults \>/= 18 years old * Recipient of LDLT Exclusion Criteria: * Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee. * Patients \< 18 years old * Patients who cannot provide informed consent * Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT) * Patients who do not wish to participate * Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable pop…
Interventions
- BiologicalMiMedx AmnioFix
MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.
Location
- Cleveland ClinicCleveland, Ohio