Figure 1

Overview of study workflow. (a) Flowchart of the clinical trial. Participants undergoing tissue transplant surgery provided informed consent and were fitted with the blood flow monitoring device at the graft site until postoperative day 7. (b) Concurrently, typical physical examinations of the graft site were performed twice daily by surgeons, as per the usual routine. Those assessments were observation of the tissue colour to determine whether it was ischemic or congestive, pin prick findings, where the tissue is pricked using a needle and the colour and speed of bleeding are observed, palpation to determine the temperature of the transplanted tissue, and a capillary refill test, which is a quick test to observe blood flow through peripheral tissue by compressing the tissue until it turns white and observing the time taken for the colour to return. (c) On the day participants underwent transplant surgery, the blood flow monitoring device was attached. Over 1 week, monitoring data collected from the device were transmitted to a tablet by a Bluetooth transmitter; thus, patients were not restricted from getting out of bed. Twice a day, surgeons performed the exam, recorded their findings, and provided a diagnosis of whether the tissue had sufficient circulation. Clinical photographs were also taken for comparison with data collected from the device. The device was removed on postoperative day 7 and the device site was assessed for abnormalities and clinical outcome. Patients then completed a questionnaire about their comfort and quality of life while wearing the device.