Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects



Status:Recruiting
Healthy:No
Age Range:18 - 60
Updated:7/21/2018
Start Date:March 2015
End Date:February 2025
Contact:Jessica Detmer-Lillard
Phone:6177327874

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Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a
deceased human donor to a patient with a large abdominal wall defect. Abdominal wall
transplantation is an innovative reconstructive procedure that has the potential to
significantly improve the lives of patients with large abdominal wall defects. The purpose of
this study is to develop the best practices for abdominal wall transplantation that will
improve the outcomes of future abdominal wall transplant recipients.

Abdominal wall transplantation surgery, the transfer of the abdominal wall tissues from a
deceased human donor to a patient with a large abdominal wall defect, is an experimental
reconstructive procedure that has the potential to significantly improve the lives of
patients.

In abdominal wall transplantation, the tissues transplanted include skin, tendons, muscles,
ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital
includes a wide variety of medical and surgical specialties.

The team BWH is actively seeking qualified candidates for the abdominal wall transplantation
research study. We will be studying a small group of people to learn more about:

- How to advance the science of abdominal wall transplantation

- How to support and limit transplant rejection issues

- How people do after abdominal wall transplantation We describe abdominal wall transplant
surgery as a life-giving procedure because it has the potential to dramatically improve,
that is to restore, both a patient's mental and physical health and his/her ability to
function and integrate in society. However, as with any other type of organ
transplantation, this improvement will require the patient to make a lifetime commitment
to taking medications that suppress the body's immune system.

Conventional reconstruction methods are always considered first, but they may provide less
than optimal results for certain patients. There are other methods available to reconstruct
the abdominal wall. However, they may yield unsatisfactory outcomes in some patients.
Abdominal wall transplantation surgery, however, has the potential to deliver these desired
functional and aesthetic benefits. Functionally, abdominal wall transplant surgery can
provide a patient with a new abdominal wall that, after extensive rehabilitation, will
provide mobility and a more natural aesthetic appearance.

From the time we begin our search for a qualified abdominal wall transplant recipient to the
continuing care we provide following surgery, a significant amount of time, expertise and
attentiveness is contributed toward making the procedure a progressive success. Abdominal
wall transplant candidates go through an extensive screening process that is likely to last
several months. This screening includes a psychiatric and social support evaluation and a
series of imaging tests to help determine a patient's physical and mental readiness for the
procedure. If, upon completion of the screening process, it is determined that a patient is a
suitable candidate, we will place the patient on a transplant waiting list. We will then
begin working with the United Network for Organ Sharing to find a donor who matches the
recipient's tissue requirements - for example similar age and correct blood type. This search
could take many months, and, if a suitable donor is not found within one year, we will speak
with the patient to determine whether he/she is willing to continue waiting.

Inclusion Criteria:

- Abdominal wall defects as described above

- Strong motivation to proceed with transplantation

- Accepts dedicating at least 2 years towards extensive post transplant rehabilitation

- Age between 18 and 60 years

- Elapsed injury-to-transplant time of more than 6 months and less than 15 years

- Reports sub-optimal outcome with conventional reconstructive procedures

- Normal liver and kidney function tests:

Exclusion Criteria:

- Record of poor compliance

- Unable to receive adequate follow-up care

- Unable to receive immune suppression either due to geographic or financial limitations

- Unable to follow strict rehabilitation schedule.

- Documented psychological disorder(s) or incomplete psychological clearance

- Impaired renal or hepatic function

- Active cancer with or without metastases

- Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable
disease
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-7796
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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