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Risks and benefits

Are there any risks involved in participating?

We want you to feel informed about the possible risks or side effects. While many people do not experience any problems, we explain below what might happen, how likely it is, and how we manage these risks.

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Sentinel skin patch surgery

During your transplant, a small piece of skin from your donor will be placed under the skin on your forearm. This “sentinel skin patch” helps doctors spot early signs of rejection more easily. Studies have shown it is safe and well tolerated. Early results suggest it may even lower the risk of rejection and mean you need less anti-rejection medicine. At first, the patch will feel numb, but some feeling may return over time. It won’t affect how your new organ works.

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While the procedure is generally safe, the following risks may occur:

  • Bruising or bleeding under the skin – up to 1 in 10 people

  • Minor skin infection – 5 to 8 in 100 people, treated with creams or tablets

  • Bleeding needing extra care – less than 5 in 100 people

  • Blood clot in the skin patch vessels needing surgery – 1 to 2 in 100 people

  • Loss of part or all of the flap – less than 2 in 100 people (this does not affect your transplant)

  • Temporary nerve irritation (e.g., pins and needles or weakness in the hand) – less than 1 in 100 people

  • Pain or tendon tightness in the forearm – less than 1 in 100 people

  • Scar - will be present at the circumference of the flap. Some people may form thicker scars.

Appearance and Long-Term Considerations

The skin flap is placed on the inner side of the forearm where it is as hidden as possible. However, it will be visible, and some people may notice it. Some patients have found the skin flap reassuring — a reminder of their transplant and a way to visually monitor their health. Others may find it a cosmetic concern.

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It is important to understand:

  • The skin tone may not match your own

  • The skin may look or feel different and may have some hair growth

  • It will not have normal sensation except for deep pressure

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A sentinel skin flap on the forearm of a patient three months after their transplant surgery

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Skin Biopsy Risks

At certain times, we will take a small skin sample (biopsy) from the flap — about the size of a pencil rubber (4 mm).

 

These biopsies help check for signs of rejection. Because the skin flap does not feel pain, no numbing medicine is needed. The risks are small:

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• Minor bleeding or bruising – less than 2 in 100 people
• Small infection – less than 1 in 100 people
• Small scar or slower healing – less than 1 in 100 people

 

Biopsies are done using sterile techniques by trained staff.

Blood sample risks

At each study visit, we will take about 50 ml of blood, which is about 3 tablespoons. This will often be taken at the same time as your routine clinical blood tests.

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The risks are very low:

  • Mild bruising or discomfort – less than 5 in 100 people

  • Feeling faint or dizzy – less than 1 in 100 people

  • Infection or vein irritation (if a regular needle is used) – less than 1 in 100 people

 

All blood samples are taken by trained healthcare professionals.

Examining Blood Sample

What are the benefits?

While we cannot promise that taking part in this study will directly benefit you, we are hopeful about the potential of the sentinel skin patch. By joining the study, you may help us discover whether this patch can allow doctors to detect and treat rejection earlier than current methods.

 

If successful, this approach could become part of routine care, helping to protect future liver and pancreas (with or without kidney) transplant patients. Your participation plays an important role in advancing transplant care and improving outcomes for many people in the years ahead.

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