Abdominal Wall Transplant

Not Applicable

Recruiting

• Conditions: Transplant;Failure,Kidney; Transplant; Failure, Bowel; Abdominal Wall Defect; Abdominal Wall Fistula; Abdominal Wall Hernia; Transplant; Failure, Liver; Abdominal Wall Injury
• Interventions: Procedure: Abdominal Wall Transplant with another solid organ transplant; Procedure: Abdominal Wall Transplant alone

• Registration Number: NCT03310905
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Start: 2018-05-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2028-01-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal Wall with Solid Organ Transplant	Abdominal Wall Transplant with another solid organ transplant	-
Isolated Abdominal Wall Transplant	Abdominal Wall Transplant alone	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with a viable abdominal wall transplant at 18 months	up to 18 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States