Abdominal Wall Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

Detailed Description
-----------------
Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months. Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.

Official Title
-----------------
Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation

Conditions
-----------------
Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel, Abdominal Wall Defect, Abdominal Wall Fistula, Abdominal Wall Hernia, Abdominal Wall Injury

Intervention / Treatment
-----------------
* Procedure: Abdominal Wall Transplant with another solid organ transplant
* Procedure: Abdominal Wall Transplant alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates between 18-65 years old Willingness and legal ability to give consent Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke Exclusion Criteria: Malignancy at evaluation or history of malignancy that precludes transplantation Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown. Medical exclusion criteria for general anesthesia Ongoing substance abuse or history of untreated substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isolated Abdominal Wall Transplant<br> | Procedure: Abdominal Wall Transplant alone<br>* Abdominal Wall Transplant alone<br>|
| Experimental: Abdominal Wall with Solid Organ Transplant<br> | Procedure: Abdominal Wall Transplant with another solid organ transplant<br>* Transplant of abdominal wall in combination with another solid organ transplant.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a viable abdominal wall transplant at 18 months |  | up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Research, Transplant, Abdominal Wall, Hernia