Recruiting

Abdominal Wall Transplantation

Sponsor:

Duke University

Code:

NCT03310905

Conditions

Transplant;Failure,Kidney

Transplant; Failure, Liver

Transplant; Failure, Bowel

Abdominal Wall Defect

Abdominal Wall Fistula

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Abdominal Wall Transplant with another solid organ transplant

Abdominal Wall Transplant alone

Study Details

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.

Conditions

Transplant;Failure,Kidney

Transplant; Failure, Liver

Transplant; Failure, Bowel

Abdominal Wall Defect

Abdominal Wall Fistula

Study ID

NCT03310905

Start date

May 1, 2018

Status verified date

Jan, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Isolated Abdominal Wall Transplant

experimental: Abdominal Wall with Solid Organ Transplant

Interventions

Abdominal Wall Transplant with another solid organ transplant

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

Abdominal Wall Transplant alone

Abdominal Wall Transplant alone

Primary outcome measure

  • Number of subjects with a viable abdominal wall transplant at 18 months [ Time Frame: up to 18 months ]

Central Contacts and Locations

Central contacts

Linda Cendales, MD

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

Kadiyala Ravindra, MD

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

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Duke University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Research
  • Transplant
  • Abdominal Wall
  • Hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-07.