RecruitingNot ApplicableNCT03310905

Abdominal Wall Transplant

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


Sponsor

Duke University

Enrollment

5 participants

Start Date

May 1, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.
  • Ongoing substance abuse or history of untreated substance abuse

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Interventions

PROCEDUREAbdominal Wall Transplant with another solid organ transplant

Transplant of abdominal wall in combination with another solid organ transplant.

PROCEDUREAbdominal Wall Transplant alone

Abdominal Wall Transplant alone


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT03310905


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