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| Name | Class |
|---|---|
| Linda Cendales, MD | UNKNOWN |
| Kadiyala Ravindra, M.D. | UNKNOWN |
| Detlev Erdmann, M.D. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated Abdominal Wall Transplant | Experimental |
| |
| Abdominal Wall with Solid Organ Transplant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Wall Transplant with another solid organ transplant | Procedure | Transplant of abdominal wall in combination with another solid organ transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with a viable abdominal wall transplant at 18 months | up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Cendales, MD | Contact | 919-681-7514 | linda.cendales@duke.edu | |
| Kadiyala Ravindra, MD | Contact | 919-613-9687 | kadiyala.ravindra@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Linda Cendales, MD | Duke University | Principal Investigator |
| Kadiyala Ravindra, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Abdominal Wall Transplant alone | Procedure | Abdominal Wall Transplant alone |
|