Campbell Jill, Chaboyer Wendy, Tobiano Georgia, Harbeck Emma, Nowicki Tracy, Moore Zena, Allen Gary, Gillespie Brigid, Coyer Fiona, Walker Rachel
Centre of Research Excellence in Wiser Wound Care, Menzies Health Institute Queensland, Griffith University, Australia.
Centre of Research Excellence in Wiser Wound Care, Menzies Health Institute Queensland, Griffith University and Gold Coast University Hospital, Gold Coast Health, Australia.
J Tissue Viability. 2022 Nov;31(4):776-782. doi: 10.1016/j.jtv.2022.07.008. Epub 2022 Jul 31.
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were recruited (70.0%) and randomised and 99 completed the trial (intervention n = 50; control n = 49) with one person withdrawn due to inappropriate recruitment (100% retention).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.
表皮下水分扫描(SEMS)是一种新型的即时护理技术,可测量局部水肿并检测可能发展为压力性损伤(PI)的早期组织损伤。它提供的客观数据可能有助于压力性损伤预防(PIP)决策。本研究旨在确定进行一项确定性随机对照试验(RCT)以测试SEMS有效性的可行性。
这项试点RCT在一家澳大利亚医院招募有发生PI风险的内科和外科患者。所有参与者均接受常规PIP护理和每日皮肤视觉评估以确定是否存在PI。干预组还接受每日SEMS检查。临床工作人员被告知表皮下水分(SEM)值是否异常,但未给予PIP建议。对患者、护理人员和结果评估者进行盲法操作并不实际。可行性结果包括招募、保留、干预保真度和患者结果。
在筛选的1185例患者中,950例被排除(80%);然后对235例进行资格评估,160例符合纳入标准(68.1%);100例被招募(70.0%)并随机分组,99例完成试验(干预组n = 50;对照组n = 49),1人因招募不当退出(保留率100%)。在预期的657次SEMS观察中,598次完成(干预保真度91%)。454个患者结果数据点中仅34个缺失(7.4%)。
大多数可行性标准得到满足,表明在医疗 - 外科患者群体中进行一项评估SEMS有效性的确定性试验是现实可行的。然而,招募可能需要大量资源并需要特定策略。