Abdominal Wall Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abdominal Wall Transplant with another solid organ transplant, Abdominal Wall Transplant alone.
- Who it may be relevant to
- Registry conditions: Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel, Abdominal Wall Defect. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
Overview
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
- 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
Primary outcome measures
- Number of subjects with a viable abdominal wall transplant at 18 months [Time frame: up to 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT03310905 · Pro00084054