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NCT Number: NCT03310905

Abdominal Wall Transplant

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.

Recruiting

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Key information

Conditions

Transplant;Failure,Kidney Abdominal Wall Defect Abdominal Wall Fistula Abdominal Wall Hernia Abdominal Wall Injury Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Transplant; Failure, Bowel Transplant; Failure, Liver

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Wall Transplant with another solid organ transplant

Procedure

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

Abdominal Wall Transplant alone

Procedure

Abdominal Wall Transplant alone

Primary outcomes

  1. Number of subjects with a viable abdominal wall transplant at 18 months

    Time frame: up to 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kadiyala Ravindra, MD

CONTACT

[email protected]

919-613-9687

Linda Cendales, MD

CONTACT

[email protected]

919-681-7514

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Detlev Erdmann, M.D.
  • Kadiyala Ravindra, M.D.
  • Linda Cendales, MD

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Oct 16, 2017
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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