Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT02158793
Eligibility Criteria:
Inclusion criteria:
* Signed and dated all required IRB approved consent forms
* Male or female recipient between the ages of 18-64 years. \* Recipients do not need to be same gender as donor\*
* Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
* Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
* Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery
* The subject is able to complete pre-transplant examination and screening procedures.
* Patient has been approved by Patient Selection Committee for placement on the recipient waiting list
* The subject is willing to continue immunosuppression regimen as directed by treating physician.
* Subject is willing and able to return to follow-up visits as described in treatment plan.
* Subjects must have autogenous tissue options available for reconstruction in event of graft failure.
* Normal GFR (glomerular filtration rate) \>60
* Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.
Exclusion criteria:
* Subject has an uncontrolled infection
* Serious co-morbidities
* Positive serology for HIV; Hepatitis B/C Antigen
* Active malignancy within 5 years with the exclusion of non-melanoma
* Subject has active substance abuse/ alcoholism
* Active Severe Psychiatric Illness
* Cognitive limitations affecting the patient's ability to provide informed consent
* Recent history of medical nonadherence
* Unstable social situation as evidence by lack of stable housing and/or lack of a supportive significant other.
* Recent history of medical non-adherence.
* Lack of stable housing and/or supportive significant other/caregiver throughout all phases of the study
* Currently active smoker within 1 year
* Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or any organic neurological disorders will not be considered for this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02158793
Study Brief:
Protocol Section:
NCT02158793