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Trials Jan 2023Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients.
METHODS
This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses.
DISCUSSION
This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19.
TRIAL REGISTRATION
ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019.
Topics: Adult; Humans; Pressure Ulcer; Australia; COVID-19; Bandages; Deafness; Silicones
PubMed: 36721259
DOI: 10.1186/s13063-022-06999-y -
International Wound Journal Aug 2023Pressure ulcers can develop in bedridden or immobile patients which physiotherapists frequently encounter. Although physiotherapists receive training for preventing...
Pressure ulcers can develop in bedridden or immobile patients which physiotherapists frequently encounter. Although physiotherapists receive training for preventing pressure ulcers, there is limited evidence of physiotherapists' knowledge level. Our study evaluated physiotherapists' pressure ulcer prevention knowledge. The level of knowledge for pressure ulcer prevention was inquired with the Turkish version of the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI-T). Two hundred and sixty-five physiotherapists participated in our study. The median PUPKAI-T total score ranged from 8 to 21. Only two physiotherapists (0.8%) got good points from the questionnaire. The highest score was Nutrition (Theme 4; 59.2%), and the lowest score belonged to the contact preventive interventions that reduce pressure/shearing (Theme 5; 26.7%). The question with the lowest success rate was the positioning question of Theme 5 (Question 2; 12.5%). In our study, physiotherapists' pressure ulcer prevention knowledge was evaluated with a relatively high number of participants compared to the literature. These results brought to mind that training programs that specifically emphasise techniques to prevent pressure ulcers and positioning manoeuvres to be organised increase the knowledge level of physiotherapists.
Topics: Humans; Physical Therapists; Pressure Ulcer; Skin Care; Surveys and Questionnaires; Health Knowledge, Attitudes, Practice
PubMed: 36535803
DOI: 10.1111/iwj.14049 -
PloS One 2023Medical device-related pressure injury (MDRPI) in intensive care unit (ICU) patients is a serious issue. We aimed to evaluate the risk factors for MDRPI associated with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Medical device-related pressure injury (MDRPI) in intensive care unit (ICU) patients is a serious issue. We aimed to evaluate the risk factors for MDRPI associated with ICU patients through systematic review and meta-analysis, and provide insights into the clinical prevention of MDRPI.
METHODS
We searched PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), WanFang Database, and China BioMedical Literature Database (CBM) (from inception to January 2023) for studies that identified risk factors of MDRPI in ICU patients. In order to avoid the omission of relevant literature, we performed a secondary search of the above database on February 15, 2023. Meta-analysis was performed using Revman 5.3.
RESULTS
Fifteen studies involving 4850 participants were selected to analyze risk factors for MDRPI in ICU patients. While conducting a meta-analysis, we used sensitivity analysis to ensure the reliability of the results for cases with significant heterogeneity among studies. When the source of heterogeneity cannot be determined, we only described the risk factor. The risk factors for MDRPI in ICU patients were elder age (OR = 1.06, 95% CI: 1.03-1.10), diabetes mellitus (OR = 3.20, 95% CI: 1.96-5.21), edema (OR = 3.62, 95% CI: 2.31-5.67), lower Braden scale score (OR = 1.22, 95%CI: 1.11-1.33), higher SOFA score (OR = 4.21, 95%CI: 2.38-7.47), higher APACHE II score (OR = 1.38, 95%CI: 1.15-1.64), longer usage time of medical devices (OR = 1.11, 95%CI: 1.05-1.19), use of vasoconstrictors (OR = 6.07, 95%CI: 3.15-11.69), surgery (OR = 4.36, 95% CI: 2.07-9.15), prone position (OR = 24.71, 95% CI: 7.34-83.15), and prone position ventilation (OR = 17.51, 95% CI: 5.86-52.36). Furthermore, we found that ICU patients who used subglottic suction catheters had a higher risk of MDRPI, whereas ICU patients with higher hemoglobin and serum albumin levels had a lower risk of MDRPI.
CONCLUSION
This study reported the risk factors for MDRPI in ICU patients. A comprehensive analysis of these risk factors will help to prevent and optimize interventions, thereby minimizing the occurrence of MDRPI.
Topics: Humans; Aged; Pressure Ulcer; Reproducibility of Results; Intensive Care Units; Critical Care; Crush Injuries; Risk Factors
PubMed: 37352180
DOI: 10.1371/journal.pone.0287326 -
International Wound Journal Jun 2015Although this article is a stand-alone article, it sets the scene for later articles in this issue. Pressure ulcers are considered to be a largely preventable problem,... (Review)
Review
Although this article is a stand-alone article, it sets the scene for later articles in this issue. Pressure ulcers are considered to be a largely preventable problem, and yet despite extensive training and the expenditure of a large amount of resources, they persist. This article reviews the current understanding of pressure ulcer aetiology: pressure, shear and microclimate. Individual risk factors for pressure ulceration also need to be understood in order to determine the level of risk of an individual. Such an assessment is essential to determine appropriate prevention strategies. The main prevention strategies in terms of reducing pressure and shear and managing microclimate are studied in this article. The problem of pressure ulceration related to medical devices is also considered as most of the standard prevention strategies are not effective in preventing this type of damage. Finally, the possibility of using dressings as an additional preventive strategy is raised along with the question: is there enough evidence to support their use?
Topics: Bandages; Humans; Pressure Ulcer; Skin Care
PubMed: 23786251
DOI: 10.1111/iwj.12107 -
The Cochrane Database of Systematic... May 2021Pressure ulcers (also known as pressure injuries) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pressure ulcers (also known as pressure injuries) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Foam surfaces (beds, mattresses or overlays) are widely used with the aim of preventing pressure ulcers.
OBJECTIVES
To assess the effects of foam beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting.
SEARCH METHODS
In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials that allocated participants of any age to foam beds, mattresses or overlays. Comparators were any beds, mattresses or overlays.
DATA COLLECTION AND ANALYSIS
At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a foam surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses.
MAIN RESULTS
We included 29 studies (9566 participants) in the review. Most studies were small (median study sample size: 101 participants). The average age of participants ranged from 47.0 to 85.3 years (median: 76.0 years). Participants were mainly from acute care settings. We analysed data for seven comparisons in the review: foam surfaces compared with: (1) alternating pressure air surfaces, (2) reactive air surfaces, (3) reactive fibre surfaces, (4) reactive gel surfaces, (5) reactive foam and gel surfaces, (6) reactive water surfaces, and (7) another type of foam surface. Of the 29 included studies, 17 (58.6%) presented findings which were considered at high overall risk of bias.
PRIMARY OUTCOME
pressure ulcer incidence Low-certainty evidence suggests that foam surfaces may increase the risk of developing new pressure ulcers compared with (1) alternating pressure (active) air surfaces (risk ratio (RR) 1.59, 95% confidence interval (CI) 0.86 to 2.95; I = 63%; 4 studies, 2247 participants), and (2) reactive air surfaces (RR 2.40, 95% CI 1.04 to 5.54; I = 25%; 4 studies, 229 participants). We are uncertain regarding the difference in pressure ulcer incidence in people treated with foam surfaces and the following surfaces: (1) reactive fibre surfaces (1 study, 68 participants); (2) reactive gel surfaces (1 study, 135 participants); (3) reactive gel and foam surfaces (1 study, 91 participants); and (4) another type of foam surface (6 studies, 733 participants). These had very low-certainty evidence. Included studies have data on time to pressure ulcer development for two comparisons. When time to ulcer development is considered using hazard ratios, the difference in the risk of having new pressure ulcers, over 90 days' follow-up, between foam surfaces and alternating pressure air surfaces is uncertain (2 studies, 2105 participants; very low-certainty evidence). Two further studies comparing different types of foam surfaces also reported time-to-event data, suggesting that viscoelastic foam surfaces with a density of 40 to 60 kg/m may decrease the risk of having new pressure ulcers over 11.5 days' follow-up compared with foam surfaces with a density of 33 kg/m (1 study, 62 participants); and solid foam surfaces may decrease the risk of having new pressure ulcers over one month's follow-up compared with convoluted foam surfaces (1 study, 84 participants). Both had low-certainty evidence. There was no analysable data for the comparison of foam surfaces with reactive water surfaces (one study with 117 participants). Secondary outcomes Support-surface-associated patient comfort: the review contains data for three comparisons for this outcome. It is uncertain if there is a difference in patient comfort measure between foam surfaces and alternating pressure air surfaces (1 study, 76 participants; very low-certainty evidence); foam surfaces and reactive air surfaces (1 study, 72 participants; very low-certainty evidence); and different types of foam surfaces (4 studies, 669 participants; very low-certainty evidence). All reported adverse events: the review contains data for two comparisons for this outcome. We are uncertain about differences in adverse effects between foam surfaces and alternating pressure (active) air surfaces (3 studies, 2181 participants; very low-certainty evidence), and between foam surfaces and reactive air surfaces (1 study, 72 participants; very low-certainty evidence). Health-related quality of life: only one study reported data on this outcome. It is uncertain if there is a difference (low-certainty evidence) between foam surfaces and alternating pressure (active) air surfaces in health-related quality of life measured with two different questionnaires, the EQ-5D-5L (267 participants) and the PU-QoL-UI (233 participants). Cost-effectiveness: one study reported trial-based cost-effectiveness evaluations. Alternating pressure (active) air surfaces are probably more cost-effective than foam surfaces in preventing pressure ulcer incidence (2029 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Current evidence suggests uncertainty about the differences in pressure ulcer incidence, patient comfort, adverse events and health-related quality of life between using foam surfaces and other surfaces (reactive fibre surfaces, reactive gel surfaces, reactive foam and gel surfaces, or reactive water surfaces). Foam surfaces may increase pressure ulcer incidence compared with alternating pressure (active) air surfaces and reactive air surfaces. Alternating pressure (active) air surfaces are probably more cost-effective than foam surfaces in preventing new pressure ulcers. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and by blinding adjudicators of the photographs to group allocation. Further review using network meta-analysis will add to the findings reported here.
Topics: Aged; Aged, 80 and over; Air; Bedding and Linens; Beds; Bias; Female; Gels; Humans; Incidence; Male; Middle Aged; Pressure Ulcer; Randomized Controlled Trials as Topic; Viscoelastic Substances
PubMed: 34097765
DOI: 10.1002/14651858.CD013621.pub2 -
The Journal of Spinal Cord Medicine Mar 2023Pressure ulcers or injuries, arise from ischemic damage to soft tissues induced by unrelieved pressure over a bony prominence. They are usually difficult to treat with... (Review)
Review
CONTEXT
Pressure ulcers or injuries, arise from ischemic damage to soft tissues induced by unrelieved pressure over a bony prominence. They are usually difficult to treat with standard medical therapy and often they recur. In the search for better treatment options, promising alternative forms of treatment are today emerging. Within the field of regenerative medicine, ongoing research on advanced therapies seeks to develop medicinal products based on gene therapy, somatic cell therapy, tissue-engineering and combinations of these.
OBJECTIVE
The main objective is to perform an overview of experimental and clinical developments in somatic cell therapy and tissue engineering targeting the treatment of pressure injuries.
METHODS
Searching terms as "PRESSURE ULCER", "STEM CELL THERAPY", "TISSUE ENGINEERING" or "WOUND HEALING" were used in combination or alone, including publications refered to basic and clinical research and focusing on articles showing results obtained in a clinical context. A total of 80 references are cited, including 23 references published in the 3 last years.
RESULTS
The results suggest that this form of treatment could be an interesting option in patients with difficult-to-treat ulcers as spinal cord injury patients.
CONCLUSION
This field of regenerative medicine is very broad and further research is warranted.
Topics: Humans; Pressure Ulcer; Spinal Cord Injuries; Stem Cells; Ulcer; Wound Healing
PubMed: 33905315
DOI: 10.1080/10790268.2021.1916155 -
Journal of Wound Care Feb 2020
Topics: Consensus Development Conferences as Topic; Equipment and Supplies; Humans; Practice Guidelines as Topic; Pressure Ulcer
PubMed: 32058852
DOI: 10.12968/jowc.2020.29.2.77 -
International Wound Journal Sep 2023The aim of this systematic review and meta-analysis is to provide an overview of the prevalence of pressure ulcers (PU) in orthopaedic wards. A comprehensive, systematic... (Meta-Analysis)
Meta-Analysis Review
The aim of this systematic review and meta-analysis is to provide an overview of the prevalence of pressure ulcers (PU) in orthopaedic wards. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science, and Persian electronic databases such as Iranmedex, and Scientific Information Database (SID) using keywords extracted from Medical Subject Headings such as "Prevalence", "Pressure ulcer", "Pressure sore", and "Orthopaedics" from the earliest to February 1, 2023. The appraisal tool for cross-sectional studies (AXIS tool) evaluates the quality of the included studies. Finally, 11 studies were included in the final analysis. The results indicated that the prevalence of PU in orthopaedic departments was 18% (ES: 0.18, 95% CI: 0.10-0.26, Z = 4.53, I : 99.09%). Although the odds ratio of PU was lower in men than women, it was not statistically significant (OR: 0.91, 95% CI: 0.74-1.11, Z = 0.95, I : 17.4%, P = .34). Also, results showed the prevalence of PU was higher among studies with a sample size of more than 200 (ES: 0.19, 95% CI: 0.10-0.28, Z = 4.07, I : 99.1%), Europe region (ES: 0.20, 95% CI: 0.14-0.26, Z = 6.7, I : 93.0%) and prospective design (ES: 0.23, 95% CI: 0.18-0.27, Z = 9.47, I : 83.3%) when compared with other sub-groups. In sum, considering the 18% prevalence of PU in the orthopaedic department, it is recommended to focus on detecting risk factors and design interventions to reduce PU in the patients admitted orthopaedic department.
Topics: Male; Humans; Female; Ulcer; Cross-Sectional Studies; Risk Factors; Hospitals; Europe; Pressure Ulcer
PubMed: 36960790
DOI: 10.1111/iwj.14156 -
International Wound Journal Mar 2024This review aims to systematically evaluate the association between hypertension and pressure ulcer (PU). PubMed, Embase, Web of Science, and Cochrane Library were... (Meta-Analysis)
Meta-Analysis Review
This review aims to systematically evaluate the association between hypertension and pressure ulcer (PU). PubMed, Embase, Web of Science, and Cochrane Library were searched for studies from their inception until September 12, 2023. Literature search, data extraction, and quality assessment were conducted independently by two researchers. The random-effects model was used to calculate the combined odds ratio (OR) and corresponding 95% confidence interval (CI) of hypertension in patients with PU; subgroup analyses were performed to explore the source of between-study heterogeneity; sensitivity analysis was used to test the robust of the combined result; and funnel plot and Egger's test were used to assess the publication bias. Finally, a total of 19 studies with 564 716 subjects were included; the overall pooled result showed no significant association between hypertension and risk of developing PU (OR = 1.15, 95% CI = 0.90-1.47, p = 0.27); and the sensitivity analysis and publication bias analysis showed robust of the combined result. Subgroup analysis indicated a significant association between hypertension and PU when the primary disease was COVID-19 (OR = 1.73, 95% CI = 1.35-2.22, p < 0.0001). No association between hypertension and PU was seen in subgroup analysis on the patient source and study design. In sum, there is no significantly statistical association between hypertension and the occurrence of PU in most cases, while the risk of PU significantly elevates among COVID-19 patients combined with hypertension regardless of patient source and study design.
Topics: Humans; Pressure Ulcer; Hypertension; Research Design; COVID-19
PubMed: 38494175
DOI: 10.1111/iwj.14829 -
Inquiry : a Journal of Medical Care... 2023Turning and repositioning is considered one of the strategies to reduce the incidence of pressure injuries (PIs) among hospitalized patients, as it helps to redistribute... (Review)
Review
Turning and repositioning is considered one of the strategies to reduce the incidence of pressure injuries (PIs) among hospitalized patients, as it helps to redistribute and minimize direct pressure on the targeted skin and enhance blood perfusion in the affected areas. The frequency of turning and repositioning is generally uniform across clinical settings, with most clinical guidelines recommending a substantial change in a patient's position according to their health status. Notably, the optimal time interval between the position changes has not yet been established. Therefore, this study aimed to review the current literature in relation to the frequency of turning and repositioning adult patients to prevent PIs. The author used a systematic review following Whittemore and Knafl's review strategy. The author used the following databases: CINAHL, Scopus, PubMed, ProQuest, Ovid, MedLine, Web of Science, and Google Scholar. During the search, Boolean logic operators, MeSH terms, and keywords were utilized. The researcher followed the Johns Hopkins Nursing Evidence-based Practice Grading Scale to evaluate the quality of selected studies. The search yielded 723 articles, of which 10 were included in this review. These 10 articles revealed several frequency intervals for comparison purposes: 2-hourly, 3-hourly, 4-hourly, and 6-hourly depending on the healthcare setting, with a combination of supine, 30° tilt, or 90° tilt. This review shows that the optimal frequency of turning and repositioning to prevent PIs remains unclear and further investigation is necessary. Considering the varying nature of clinical settings, there is a lack of clarity regarding a golden standard for the same. Therefore, patients' health conditions should be considered when choosing the proper frequency to prevent PIs.
Topics: Humans; Adult; Pressure Ulcer; Health Facilities; Incidence; Health Status; Hospitals
PubMed: 38050921
DOI: 10.1177/00469580231215209