NCT03310905

Abdominal Wall Transplant

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Abdominal Wall Transplant with another solid organ transplant	Transplant of abdominal wall in combination with another solid organ transplant.
PROCEDURE	Abdominal Wall Transplant alone	Abdominal Wall Transplant alone

Timeline

• Start date: 2018-05-01
• Primary completion: 2028-01-01
• Completion: 2028-06-01
• First posted: 2017-10-16
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States