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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.
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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Living Donor Liver Transplant (LDLT) graft recipient | Other | LDLT recipient with MiMedx placental graft placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiMedx AmnioFix | Biological | MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biliary complications | Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture. | 1 year post living donor liver transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Complication Rates | Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection | 1 year post living donor liver transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erlind Allkushi | Contact | 2164440223 | allkuse2@ccf.org | |
| Mary Bilancini | Contact | 2164448983 | bilancm@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Choon Hyuck D Kwon, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Post-operative Hospital Length of Stay |
Hospital length of stay |
| From date of transplant until date of discharge from hospital, assessed up to 365 days |
| Post-operative ICU Length of Stay | ICU length of stay (days) | From date of transplant until date of transfer out of ICU, assessed up to 365 days |
| Readmissions | Number of readmissions post-operatively | 1 year post living donor liver transplant |