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.
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
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
Parallel
Abdominal Wall Transplant with another solid organ transplant
Procedure/SurgeryTransplant of abdominal wall in combination with another solid organ transplant.
Abdominal Wall Transplant alone
Procedure/SurgeryAbdominal Wall Transplant alone
Number of subjects with a viable abdominal wall transplant at 18 months
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Duke University
Lead sponsor
Linda Cendales, MD
Collaborator
Kadiyala Ravindra, M.D.
Collaborator
Detlev Erdmann, M.D.
Collaborator
