RESUMO
BACKGROUND: Pressure injuries in intensive care patients are a safety issue. Specialized foam sacral prophylactic dressings prevent pressure injuries with several products available for clinicians to choose from. OBJECTIVES: Assess the feasibility of conducting a multisite trial to test the effectiveness of two dressings versus usual care in preventing sacral pressure injuries in intensive care patients. METHODS: Using a three-arm pilot randomized trial design, adult intensive care unit patients at risk for pressure injuries were randomly allocated to the Mepilex® Sacrum dressing, the Allevyn™ Life Sacrum dressing or the control group. Daily pressure injury data were collected including a de-identified sacral photograph, which the blinded outcome assessor used to determine the study end point: a new sacral pressure injury. Pre-determined feasibility criteria were measured in terms of eligibility, recruitment, retention, intervention fidelity and missing data. RESULTS: From May-September 2021, we screened 602 intensive care unit adult patients for eligibility with 93 % (n = 558) excluded. Forty-four (7 %) were eligible, and all were recruited and randomized (100 %). After receipt of the intervention two participants withdrew from the study. Our final sample of 42 participants were randomly allocated to the Mepilex® (n = 12), Allevyn™ (n = 14) or control (n = 16) group. The interventions were delivered as intended and there were 11 (6 %) cases of missing outcome data. Five participants (12 %) developed a sacral pressure injury, four of whom received a sacral dressing. CONCLUSIONS: A larger trial is feasible with minor refinement to the length of stay eligibility criterion. IMPLICATIONS FOR PRACTICE: Prophylactic sacral dressings are recommended for pressure injury prevention. Determining the feasibility of a larger trial to test the effectiveness of two dressings versus usual care in preventing sacral pressure injuries in intensive care patients can provide evidence to aid clinicians, policy makers and managers make value-based care decisions.
Assuntos
Bandagens , Estudos de Viabilidade , Unidades de Terapia Intensiva , Úlcera por Pressão , Humanos , Úlcera por Pressão/prevenção & controle , Masculino , Feminino , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Pessoa de Meia-Idade , Bandagens/normas , Idoso , Adulto , Sacro/lesões , Projetos PilotoRESUMO
BACKGROUND: Numerous interventions for pressure injury prevention have been developed, including care bundles. OBJECTIVE: To systematically review the effectiveness of pressure injury prevention care bundles on pressure injury prevalence, incidence, and hospital-acquired pressure injury rate in hospitalised patients. DATA SOURCES: The Medical Literature Analysis and Retrieval System Online (via PubMed), the Cumulative Index to Nursing and Allied Health Literature, EMBASE, Scopus, the Cochrane Library and two registries were searched (from 2009 to September 2023). STUDY ELIGIBILITY CRITERIA: Randomised controlled trials and non-randomised studies with a comparison group published in English after 2008 were included. Studies reporting on the frequency of pressure injuries where the number of patients was not the numerator or denominator, or where the denominator was not reported, and single subgroups of hospitalised patients were excluded. Educational programmes targeting healthcare professionals and bundles targeting specific types of pressure injuries were excluded. PARTICIPANTS AND INTERVENTIONS: Bundles with ≥3 components directed towards patients and implemented in ≥2 hospital services were included. STUDY APPRAISAL AND SYNTHESIS METHODS: Screening, data extraction and risk of bias assessments were undertaken independently by two researchers. Random effects meta-analyses were conducted. The certainty of the body of evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation. RESULTS: Nine studies (seven non-randomised with historical controls; two randomised) conducted in eight countries were included. There were four to eight bundle components; most were core, and only a few were discretionary. Various strategies were used prior to (six studies), during (five studies) and after (two studies) implementation to embed the bundles. The pooled risk ratio for pressure injury prevalence (five non-randomised studies) was 0.55 (95â¯% confidence intervals 0.29-1.03), and for hospital-acquired pressure injury rate (five non-randomised studies) it was 0.31 (95â¯% confidence intervals 0.12-0.83). All non-randomised studies were at high risk of bias, with very low certainty of evidence. In the two randomised studies, the care bundles had non-significant effects on hospital-acquired pressure injury incidence density, but data could not be pooled. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Whilst some studies showed decreases in pressure injuries, this evidence was very low certainty. The potential benefits of adding emerging evidence-based components to bundles should be considered. Future effectiveness studies should include contemporaneous controls and the development of a comprehensive, theory and evidence-informed implementation plan. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42023423058. TWEETABLE ABSTRACT: Pressure injury prevention care bundles decrease hospital-acquired pressure injuries, but the certainty of this evidence is very low.