Craniomaxillofacial and Upper Extremity Allotransplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Craniofacial Injuries
- Face Injuries
- Facial Deformity
- Facial Injuries
- Hand Injuries
- Upper Extremity Injuries
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a prospective longitudinal observational analysis of functional and aesthetic outcomes after treatment of severe facial defects and upper extremity injuries with microvascular composite tissue allotransplantation. There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
Description
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper ext...
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper extremity constitutes the part of the body including arm, forearm and hand. This procedure is called combined craniomaxillofacial and upper extremity allotransplantation or "combined face and upper extremity transplant". This study will also collect data on how patients do during and after having a combined face and upper extremity transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits. Participants are invited to take part in this research study who have suffered severe injury to the face and upper extremity and previous surgeries to repair the injury have not restored function, appearance, and sensation. Participants must have attempted a trial of prosthetics (artificial upper extremity), if at all possible.
Tracking Information
- NCT #
- NCT04057638
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eduardo Rodriguez, MD, DDS NYU Langone Medical Center
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