Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT02331355 |
Other study ID # |
HUM00078607 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 2016 |
Est. completion date |
November 2020 |
Study information
Verified date |
November 2020 |
Source |
University of Michigan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
There is an urgent need to develop hand transplant programs in this country. To this end, the
University of Michigan Hospital and Health Systems is developing such an interdisciplinary
program. The Transplant Center would like to track the patient experience from pre-operative
care through surgery and post-operative care.
Detailed information will be collected from the patient medical records, including:
Pre-operative screening, demographics, medications; Surgical information ; Post-operative
inpatient and out-patient care; laboratory and other test results; physical assessments,
psychological assessments and quality of life assessments.
Description:
Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple
tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is
useful for functional restoration of patients with severe tissue loss as encountered with
massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA,
and specifically hand transplantation, combines the technical excellence of hand
surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ
transplantation. The technical demands of hand transplantation, enhanced donor antigen burden
of the hand allograft, and complex psychosocial issues pertaining to the recipient account
for much of the discrepancy between these 2 related fields.
Detailed information will be collected from the patient medical records, including:
Pre-operative screening, demographics, medications; surgical information ; post-operative
inpatient and out-patient care; laboratory and other test results; physical assessments,
psychological assessments and quality of life assessments.
Specific outcomes will include allograft survival, allograft rejection, allograft
functionality, and quality of life from transplant through 5 years.