Abdominal Wall Transplant

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03310905

Enrollment

Registered

2017-10-16

Start date

2018-05-01

Completion date

2028-06-01

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Research, Transplant, Abdominal Wall, Hernia

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.

Interventions

PROCEDUREAbdominal Wall Transplant with another solid organ transplant

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

PROCEDUREAbdominal Wall Transplant alone

Abdominal Wall Transplant alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Number of subjects with a viable abdominal wall transplant at 18 months	up to 18 months

Countries

United States

Contacts

Primary ContactLinda Cendales, MD

linda.cendales@duke.edu919-681-7514

Backup ContactKadiyala Ravindra, MD

kadiyala.ravindra@duke.edu919-613-9687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026