A small patch of skin from a lung donor, transplanted alongside the new organ, could give doctors an early warning sign of rejection before the lung itself is damaged. Lung transplant recipients must take lifelong immunosuppressive drugs, yet rejection remains common and hard to spot early. Current diagnosis relies on invasive biopsies or late-appearing symptoms. The skin flap—visible to the naked eye—turns red and rash-like at the first signs of immune attack, offering a simple, continuous monitoring tool. This trial will randomise 152 UK lung transplant patients to receive either standard care or an additional sentinel skin flap from the same donor. If the flap reliably flags rejection earlier, doctors could treat it before irreversible organ injury occurs. This might allow some patients to safely reduce their immunosuppression, cutting side effects and infection risk. The study will also track whether the flap itself alters immune responses, potentially revealing new mechanisms of transplant tolerance. If successful, the approach could become standard practice in NICE guidelines and extend beyond lungs to other solid organ transplants.
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Research Question: In solid organ transplantation (SOT) does the simultaneous transplantation of a skin flap from the same donor reduce the risk of rejection and thus improve the survival of the organ transplant? Background: 4,300 patients a year receive a SOT in the UK. Recipients take lifelong immunosuppressive medication to avoid rejection of the transplanted organ. Despite immunosuppression, rejection is a problem and must be treated early to prevent chronic organ damage or loss. However, diagnosis of early rejection is difficult to discriminate from infection or other causes, and signs of rejection occur late in the process. Use of a continuously visible Sentinel Skin Flap (SSF) from the same donor may allow early detection and treatment of rejection. The skin shows a visible rash with early rejection providing easy continuous immune-monitoring. This facilitates earlier detection and treatment of rejection, before organ injury, prolonging organ survival and may even permit titratable reduction of immunosuppression and reduction in invasive tests. Results from intestinal and pancreas/kidney transplant studies in Oxford suggest that transplant of a SSF is safe and adds value in diagnosing rejection; recipients had a significantly lower than expected rate of transplant organ rejection. This novel technique should be investigated in other SOTs. Aims: We aim to establish if combining a simultaneous SSF transplant with a SOT reduces rejection in the transplanted organ, protects it from immunological injury leading to improved longer-term outcomes, and to determine the mechanism. Methods: This is a multi-centre RCT set in the 5 cardiothoracic transplant units in the UK. We aim to recruit 152 adult patients on the list for lung transplantation. Patients that consent to recruitment will be allocated 1:1 to receive a SSF transplant alongside their lung transplant or standard lung transplant care with no SSF transplant. All other tests or treatments are at the discretion of the treating clinician. Participants will be followed-up at 6 weeks, 3, 6 and 12 months and in line with routine local clinical practice. The primary outcome is skin or organ rejection within 12 months, defined by biopsy-proven acute rejection . Secondary outcomes include clinical, safety and health-related quality of life outcomes. The diagnostic accuracy of the SSF will be assessed against the current reference standard. Mechanistic studies will identify the mechanism of immune-modulation by simultaneous transplant of skin/SOT and immune pathways in skin and SOT rejection. Long-term outcomes will be assessed at 5-years (beyond the duration of the grant) using routinely collected clinical and safety data from NHSBT. Timelines for delivery: The total length of the grant is 60 months. Recruitment will last for 36 months. There will be a formal stop/go review of the internal pilot in month 18 of the project (after 9 months of recruitment) to ensure a minimum of 20 patients have been randomised and all centres have been opened to recruitment. If the target is met, the trial will continue to recruit for a further 27 months. Anticipated impact and Dissemination: If this trial shows the addition of a SSF is beneficial it is anticipated that SSFs will be adopted into NICE guidelines and become standard of care worldwide. Study results will be disseminated to participants via the SITU website, transplant units, NHSBT, patient groups and charities.
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