The effect of sub-epidermal moisture on pressure injury prevention strategies and incidence of pressure injuries: A feasibility pilot randomised controlled trial.

Sub-epidermal moisture scanning (SEMS) is a novel point-of-care technology that measures localised oedema and detects early tissue damage that may develop into a pressure injury (PI). It provides objective data that may assist PI prevention (PIP) decision making. This study aimed to determine the feasibility of undertaking a definitive randomised controlled trial (RCT) to test the effectiveness of SEMS. This pilot RCT recruited medical and surgical patients at risk of developing a PI in one Australian hospital. All participants received routine PIP care and daily visual skin assessment to determine the presence of a PI. The intervention group also received daily SEMS. Clinical staff were told if the sub-epidermal moisture (SEM) value was abnormal but were not given advice for PIP. Blinding of patients, care staff and outcome assessors was not practical. Feasibility outcomes included recruitment, retention, intervention fidelity, and patient outcomes. Of 1185 patients screened prior to eligibility, 950 were excluded (80%); 235 were then assessed for eligibility and 160 met the inclusion criteria (68.1%); 100 were recruited (70.0%) and randomised and 99 completed the trial (intervention n = 50; control n = 49) with one person withdrawn due to inappropriate recruitment (100% retention). Of the 657 expected SEMS observations, 598 were completed (91% intervention fidelity). Only 34 of 454 (7.4%) patient outcome data points were missing. Most feasibility criteria were met, indicating a definitive trial to assess the effectiveness of SEMS in a medical-surgical patient population is realistic. However, recruitment may be resource intensive and require specific strategies.

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Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jill Campbell reports a relationship with Hartmann Pty Ltd that includes: consulting or advisory. Zena Moore reports a relationship with BBI Global Scientific Advisory Board that includes: board membership and consulting or advisory. Gary Allen reports a relationship with Australasian Human Research Ethics Consultancy Services that includes: employment. Fiona Coyer reports a relationship with Molnlycke Pty Ltd that includes: consulting or advisory. School of Nursing & Midwifery, RCSI, has a research collaboration with BBI.