Sentinel skin flap in lung transplant RCT
Research type
Research Study
Full title
Efficacy and mechanism of sentinel skin flap reduction of solid organ (lung) transplant rejection: A randomised controlled trial
IRAS ID
318347
Contact name
Henk Giele
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics & Assurance Team (RGEA)
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Transplanted organs such as lungs, hearts, kidneys and pancreases are subject to attack by the immune system causing rejection of the transplanted organ. Rejection is prevented by immunosuppression medication that interferes with the body’s immune system and hinders rejection. Despite these medications rejection still occurs. If rejection is not detected and treated early enough the transplanted organ scars and stops working. Detecting rejection is difficult as it does not have specific features. In lung transplants attempts are made to detect rejection by frequent hospital visits for chest x-rays, blood tests and biopsies of the transplanted lung performed by putting a tube into the airway down into the lung. These tests are performed very regularly or of the patient has symptoms of lung disease such as cough. All these tests can show are if there is inflammation but there is no specific measure of rejection until the rejection is very severe.
We discovered when we were doing intestinal transplants which included skin transplants that the skin displayed a easily visible rash when rejection was occurring, and that this sign was present before the intestine transplant rejected. The skin was visible continuously, so we did not have to rely on intermittent biopsies or other tests, but only performed these when the skin indicated there was rejection. As a result of this we began a trial, transplanting a patch of skin with pancreas and kidney transplants. Our preliminary results show that the skin not only acts as a monitor for rejection but also reduces the risk of rejection in transplants.
We wish to repeat this study in lung transplants to see if a skin transplant can act as a rejection monitor for lung transplants, reduce the immune suppression drug levels, and avoid rejection injury to the lungs.REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0248
Date of REC Opinion
24 May 2023
REC opinion
Further Information Favourable Opinion