Abdominal Wall Transplant

Duke University

Status: Enrolling

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

Treatments: Procedure: Abdominal Wall Transplant with another solid organ transplant; Procedure: Abdominal Wall Transplant alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03310905

Pro00084054

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Isolated Abdominal Wall Transplant

Experimental group

Treatment:

Procedure: Abdominal Wall Transplant alone

Abdominal Wall with Solid Organ Transplant

Experimental group

Treatment:

Procedure: Abdominal Wall Transplant with another solid organ transplant