Clinical trial NCT03310905: Abdominal Wall Transplant
Official title: Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transplant;Failure,Kidney
Transplant; Failure, Liver
Transplant; Failure, Bowel
Abdominal Wall Defect
Abdominal Wall Fistula
Abdominal Wall Hernia
Abdominal Wall Injury
Keywords: Research
Transplant
Abdominal Wall
Hernia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Linda Cendales, MD
name: Kadiyala Ravindra, M.D.
name: Detlev Erdmann, M.D.
First posted: 2017-10-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects with a viable abdominal wall transplant at 18 months
timeFrame: up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Linda Cendales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kadiyala Ravindra, MD
role: PRINCIPAL_INVESTIGATOR
References: