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Contact Information:

Dr Jessica Scaife
-
jessica.scaife@nds.ox.ac.uk


Ms Aimee Henessy
-
ssftrial@nds.ox.ac.uk


Prof Henk Giele
-
henk.giele@mac.com


Study Location:

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Be Part of Research - Trial Details - Transplanting patches of skin with lung transplants to help prevent and detect rejection

Transplanting patches of skin with lung transplants to help prevent and detect rejection

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Organ rejection


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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.
The aim of the SENTINEL study is to find out whether transplanting both lung and a patch of skin (called a sentinel skin flap) from the same donor helps to reduce rejection of the lung.
The skin will be transplanted onto the under-surface of the lower arm.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Dec 2023 31 Dec 2026

SENTINEL is a randomised study: We are making a direct comparison between people who have lung transplant only or lung transplant and sentinel skin flap. Patients who agree to participate in the study will be randomly allocated to one of the treatment groups. We are inviting everyone who is waiting for lung transplant to consider taking part. The study will transplant 152 people: half will get a skin flap with their lung transplant, and the other half will not. We will follow patients up over 12 months. They will attend their usual hospital visits 3, 6 and 12 months after transplant. At these visits, clinical and research biopsies and other samples will be collected. We will record lung function and quality of life measures as well. We will investigate any suspected episodes of rejection, and we will record data and take samples on these occasions.


Adults over 18 years, scheduled for lung transplant surgery.

You can take part if:



You may not be able to take part if:


1. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to comply with trial procedures2. Severe peripheral vascular disease with no vessels available for inset of the skin flap


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital
    University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Freeman Hospital
    The Newcastle upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal Papworth Hospital NHS Foundation Trust
    Papworth Road Cambridge Biomedical Campus
    Cambridge
    CB2 0AY
  • Harefield Hospital
    Guys and St Thomas' NHS Foundation Trust 249 Westminster Bridge Road
    London
    SE1 7EH
  • Wythenshawe Hospital
    Manchester University NHS Foundation Trust Cobbett House Oxford Road
    Manchester
    M13 9WL

The only extra tests we do as part of the study are blood tests and skin biopsies taken at standard appointments. There is a risk that patients may not like the skin flap. If this is the case, we can remove it. This study will provide evidence which we hope will change the pathway for lung transplant and improve outcomes for patients. It could also help pave the way for skin flap transplant to be used in all organ transplants.

Ms Aimee Henessy
-
ssftrial@nds.ox.ac.uk


Prof Henk Giele
-
henk.giele@mac.com


Dr Jessica Scaife
-
jessica.scaife@nds.ox.ac.uk



The study is sponsored by University of Oxford and funded by NIHR EME.




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Read full details for Trial ID: ISRCTN13844252

Or CPMS 55602

Last updated 28 March 2024

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