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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01281267
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 60 years.
* Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
* The facial defect cannot be restored with traditional reconstruction techniques.
* Signed written informed consent.
* Willing to complete psychological and social evaluations.
* Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
* Willing to return for follow-up visits as determined by the treating physician and to comply with extensive post-transplant rehabilitation therapy.
* Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.
Exclusion Criteria:
* Active malignancy.
* High risk of return of malignancy.
* History of persistent non-compliance.
* Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
* Any diagnosis that puts the subject at risk during the face transplant surgery.
* Absence of adequate donor sites for skin grafting in the event of transplant failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01281267
Study Brief:
Protocol Section:
NCT01281267