RECRUITING

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.

Official Title

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Quick Facts

Study Start:2015-03-01
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02416674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Abdominal wall defects as described above
  2. * Strong motivation to proceed with transplantation
  3. * Accepts dedicating at least 2 years towards extensive post transplant rehabilitation
  4. * Age between 18 and 60 years
  5. * Elapsed injury-to-transplant time of more than 6 months and less than 15 years
  6. * Reports sub-optimal outcome with conventional reconstructive procedures
  7. * Normal liver and kidney function tests:
  1. * Record of poor compliance
  2. * Unable to receive adequate follow-up care
  3. * Unable to receive immune suppression either due to geographic or financial limitations
  4. * Unable to follow strict rehabilitation schedule.
  5. * Documented psychological disorder(s) or incomplete psychological clearance
  6. * Impaired renal or hepatic function
  7. * Active cancer with or without metastases
  8. * Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable disease

Contacts and Locations

Study Contact

Jessica Detmer-Lillard
CONTACT
6177327874

Principal Investigator

Bohdan Pomahac, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Bohdan Pomahac, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-03-01
Study Completion Date2025-02

Study Record Updates

Study Start Date2015-03-01
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • abdominal wall
  • vascularized composite allotransplantation

Additional Relevant MeSH Terms

  • Abdominal Wall Defect