Abdominal Wall Transplant

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDuke University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Abdominal Wall Transplant with another solid organ transplant
  • Abdominal Wall Transplant alone

Treatment groups

5 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

Linda Cendales, MD

Collaborator

Kadiyala Ravindra, M.D.

Collaborator

Detlev Erdmann, M.D.

Collaborator