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Recruiting NCT03310905

Abdominal Wall Transplant

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Plain-language summary for patients

Trial Parameters

Condition Transplant;Failure,Kidney
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 5
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2018-05-01
Completion 2028-01-01
Interventions
Abdominal Wall Transplant with another solid organ transplantAbdominal Wall Transplant alone

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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.

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

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