Question 1

What is the purpose of this study?

Accepted Answer

This is a feasibility trial designed to explore whether liver, pancreas, and kidney transplant patients who receive a small patch of skin, transplanted onto their forearm (from the same donor as the solid organ), may benefit from this. The aim of this feasibility study is to assess whether this approach is acceptable to patients and clinical teams, and to inform the design of a larger trial.

This patch of skin is called a sentinel skin flap (SSF) because it can act as an early warning system, potentially showing a visible rash if the transplanted organ is rejecting. By detecting signs of rejection earlier than current methods, the flap may help prevent damage to the transplanted organ.

Question 2

Are there any benefits from being included in this research study?

Accepted Answer

Your relative will not benefit directly from taking part in this study but the information we will obtain will provide further knowledge of organ rejection and how it can be detected early.

Question 3

Why has my relative been chosen?

Accepted Answer

Your relative has been chosen because they are a deceased organ donor, and their participation in this study could provide valuable insights into transplant processes. The study aims to improve the understanding of transplant rejection and enhance the success of organ transplants. Their involvement could help further this important research, potentially benefiting future transplant patients.

Question 4

Why have I been approached?

Accepted Answer

Normally patients are included in medical research studies only if they agree to be included in the study and understand what is involved (“Informed Consent”). In medical research into conditions where the patient is critically ill or has passed away, and therefore unable to discuss what is involved in the research, ‘assent’ can be obtain from the patient’s relatives on their behalf. As next-of-kin we will keep you informed of what is happening with your relative. If you know of any wishes of your relative that might be relevant, you should let us know.

Question 5

What will happen if my relative is included in this research study?

Accepted Answer

If your relative is included in this study, he or she will donate a piece of skin from their forearm in addition to their organs.

Question 6

What happens if my relative is not included in the study?

Accepted Answer

If your relative is not included in this study his or her care and organ donation will not be affected in any way.

Question 7

Who is organising and funding the research?

Accepted Answer

This research is funded by: 
• Health Research Board ECSA-2024-010.
• HSE Spark innovation funding
• HSE Spark Seed funding
• PPI ignite funding.

Question 8

Has this study been reviewed by an ethics committee?

Accepted Answer

The Ethics and Medical Research Committee of St. Vincent’s Healthcare Group has reviewed and approved this study. As this study involves patients unable to participate in a discussion at the time of the study, this committee is satisfied that:

• any risks involved are minimal
 • of the two treatments being compared it is not known which is better
 • that the study is being carried out in a scientific manner with potential to benefit future patients
 • that the rights and dignity of patients will be respected.

Question 9

Who can take part?

Accepted Answer

Patients listed for liver, pancreas or kidney transplants at St Vincent’s University Hopital are invited to participate. Participation is voluntary and does not affect care. You are free to withdraw at any time without giving a reason.

Question 10

Where can I find the outcome of the study?

Accepted Answer

Upon completion results of the study will be published on www.sentinelstudy.ie