Abdominal Wall Transplant

Duke University5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transplant;Failure,Kidney Transplant; Failure, Liver Transplant; Failure, Bowel Abdominal Wall Defect Abdominal Wall Fistula Abdominal Wall Hernia Abdominal Wall Injury

Interventions

Abdominal Wall Transplant with another solid organ transplantPROCEDURE

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

Abdominal Wall Transplant alonePROCEDURE

Abdominal Wall Transplant alone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Number of subjects with a viable abdominal wall transplant at 18 months

Time frame: up to 18 months

Central Contacts

Linda Cendales, MD

CONTACT

919-681-7514 linda.cendales@duke.edu

Kadiyala Ravindra, MD

CONTACT

919-613-9687 kadiyala.ravindra@duke.edu

Data from ClinicalTrials.gov

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