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The Cochrane Database of Systematic... Jul 2021Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings.
OBJECTIVES
To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population.
SEARCH METHODS
In June 2020 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 We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional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 by language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting.
DATA COLLECTION AND ANALYSIS
At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology.
MAIN RESULTS
We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias. Primary outcomes There is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants). It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants). Secondary outcomes Moderate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference -1.39, 95% CI -1.79 to -0.98; I = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence). It is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness. Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.
Topics: Aged; Bandages, Hydrocolloid; Bias; Compression Bandages; Dermatologic Agents; Humans; Middle Aged; Pain Management; Quality of Life; Randomized Controlled Trials as Topic; Stockings, Compression; Time Factors; Varicose Ulcer; Wound Healing; Zinc Oxide
PubMed: 34308565
DOI: 10.1002/14651858.CD013397.pub2 -
International Journal of Nursing Studies Oct 2021Pressure ulcers are a common complication with a high impact on well-being and quality of life in people with impaired mobility and/or dysfunctional pain sensations.... (Review)
Review
BACKGROUND
Pressure ulcers are a common complication with a high impact on well-being and quality of life in people with impaired mobility and/or dysfunctional pain sensations. Prevention is therefore crucial. However, persons at risk seem to experience difficulties in adhering to self-management regimens that can help to prevent or diminish the development of pressure ulcers. Self-management support interventions might help to improve their self-management skills.
OBJECTIVES
To review the content, components and effectiveness of self-management support interventions on clinical and behavioral outcomes for people at risk of pressure ulcers.
METHODS
A systematic literature search for the period of January 2000 to February 2020 was conducted in five databases (CINAHL, Cochrane, PsycINFO, PubMed, and Web of Science). Inclusion criteria were: (1) studies including persons at a high risk of pressure ulcers; (2) studies investigating interventions focused on self-management support; (3) studies describing clinical and behavioral outcomes related to prevention and care of pressure ulcers. All studies were independently screened on title, abstracts and full text by two researchers. The PRISMS taxonomy of 14 components was used to code intervention content.
RESULTS
The search yielded 5297 papers, which resulted in the inclusion of 16 papers on self-management support interventions for persons at risk of pressure ulcers. Interventions focused mostly on 'Information about condition and/or management' (13 interventions), 'Training in practical self-management activities' (7 interventions), and 'Training in psychological strategies' (6 interventions). 'Provision of equipment' was not investigated. The intensity of the interventions varied in delivery mode, frequency and duration. Improvements were found in clinical outcomes in four studies and in behavioral outcomes in ten studies. Four studies showed improvements in clinical outcomes and ten studies in behavioral outcomes. Knowledge was positively influenced in eight studies.
CONCLUSION
Self-management support interventions show potential. The extensiveness and intensity of the interventions seem to be predictive for the effectiveness, but specific content components cannot be recommended. This review revealed recommendations for future research and international consensus should be reached about patient-relevant outcomes.
Topics: Humans; Pressure Ulcer; Quality of Life; Self-Management
PubMed: 34274772
DOI: 10.1016/j.ijnurstu.2021.104014 -
Journal of Tissue Viability Nov 2021Medical devices provide effective therapeutic care for patients. However, medical device-related pressure injuries (MDRPI) are caused by prolonged pressure or shear from...
Medical devices provide effective therapeutic care for patients. However, medical device-related pressure injuries (MDRPI) are caused by prolonged pressure or shear from a medical device on any location on the body, including mucosal cavities. The primary outcome of this quantitative systematic review was to identify the incidence of MDRPIs in adults within the acute hospital setting. Secondary outcomes include grading, anatomical location and devices that caused such injuries. Electronic databases (CINAHL Plus with Full Text, MEDLINE, EBSCO Host, Health Business Elite Web of Science, PsychINFO, Google Scholar, and Research Gate) were searched for all potential primary studies between November 2019-January 2020. Studies were refined to the English language only, had no time limit from publication, and had to include participants over the age of 18 years with an MDRPI in the acute hospital setting and 720 potential primary studies were identified. Fourteen articles were identified that matched the predefined criteria and were included in the review. All included studies were critically appraised using the evidence-based librarianship critical appraisal tool and data analysis and narrative synthesis were completed. The incidence of MDRPIs in adults within the acute care setting was 28.1% (SD: 29.1%, min: 1.14%, max: 100%). 71.3% of studies documented anatomical locations of MDRPIs, 36.2% included grading of MDRIs, and 71.4% studies documented the offending medical devices. The mean quality appraisal percentage of all included studies was 76.67% (SD: 4.61%; min: 66.6%, max: 83.3%). Despite the heterogeneity of the studies, the review has identified that MDRPIs are prevalent among individuals cared for within the acute hospital setting. Thus, given the morbidity associated with these wounds, it is important to develop strategies to reduce the scope of this problem.
Topics: Adult; Hospitals; Humans; Incidence; Middle Aged; Pressure Ulcer; Time Factors
PubMed: 34272123
DOI: 10.1016/j.jtv.2021.03.002 -
The Cochrane Database of Systematic... Jul 2021Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is...
BACKGROUND
Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is the second update of a review first published in 2011.
OBJECTIVES
To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in people without healed or active venous ulceration.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 May 2020. We also checked references of studies identified from the literature searches.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) involving people diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment or placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. We also included trials comparing different lengths and pressures of stockings. We excluded trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. Two review authors independently assessed trials for inclusion, extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. Outcomes of interest were change in symptoms; physiological measures; complications; compliance; comfort, tolerance and acceptability of wearing stockings; and quality of life.
MAIN RESULTS
We included 13 studies with 1021 participants with varicose veins without healed or active venous ulceration. One study included pregnant women while other studies included participants who had sought medical intervention for their varicose veins by being on surgical waiting lists, or attending vascular surgery or dermatology clinics or outpatient departments. The stockings used in the studies exerted different levels of pressure, ranging from 10 mmHg to 50 mmHg. Five studies assessed compression stockings versus no compression stockings or placebo stockings. Three of these studies used knee-length stockings, one used full-length stockings and one used full tights. Eight studies compared different types or pressures of knee-length stockings. The risk of bias of many included trials was unclear, mainly because of inadequate reporting. We were unable to pool studies as they did not report the same outcomes or used different ways to assess them. Many studies were small and there were differences in the populations studied. The certainty of the evidence was therefore low to very low. Compression stockings compared with no treatment or placebo stockings All four studies that reported change in symptoms found a subjective improvement by the end of the study. However, change in symptoms was not always analysed by comparing the randomised arms of the studies and was therefore subject to bias. Two studies assessed physiological measures using either ankle circumference or duplex sonography to measure oedema. Ankle circumference showed no clear difference between baseline and follow-up while oedema was reduced in the stocking group compared with the placebo stocking group. Three studies reported complications or side effects with itching and irritation the main side effects reported. None of the trials reported severe side effects. Reports of compliance varied between studies. One study reported a high dropout rate with low levels of compliance due to discomfort, application and appearance; two studies reported generally good levels of compliance in the stocking group compared to placebo/no treatment. Two studies reported comfort, tolerance and acceptability with outcomes affected by the study population. Compression tights were increasingly rejected by pregnant women as their pregnancy progressed, while in one study of non-pregnant women, the stockings group showed no more hindrance of normal activities and daytime discomfort when compared with placebo stockings. One study reported quality of life showing no clear differences between the stocking and placebo stocking groups. Compression stockings compared with different compression stockings All five studies that reported change in symptoms found a subjective improvement in symptoms by the end of the study. Change in symptoms was not always analysed comparing the randomised arms of the trials and was therefore subject to bias. Five studies reported a variety of physiological measures such as foot volumetry, volume reduction and change in diameter. Generally, there were no clear differences between study arms. Four studies reported complications or side effects, including sweating, itching, skin dryness, and constriction and tightness. None of the trials reported severe side effects. Two studies reported compliance showing no difference in compliance rates between stockings groups, although one study reported high initial levels of dropout due to discomfort, appearance, non-effectiveness and irritation. Four studies reported comfort, tolerance and acceptability. Two studies reported similar levels of tolerance and discomfort between groups. Discomfort was the main reason for indicating a preference for one type of stocking over another. None of the studies assessed quality of life. No conclusions regarding the optimum length or pressure of compression stockings could be made as there were no conclusive results from the included studies.
AUTHORS' CONCLUSIONS
There is insufficient high-certainty evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of large RCTs of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.
Topics: Adult; Bias; Edema; Female; Humans; Male; Pregnancy; Quality of Life; Randomized Controlled Trials as Topic; Stockings, Compression; Treatment Outcome; Varicose Ulcer; Varicose Veins
PubMed: 34271595
DOI: 10.1002/14651858.CD008819.pub4 -
Nursing Open Nov 2022Pressure injuries (PIs) are one of the most common complications related to immobility, especially in hospitalized patients, which lead to increased morbidity, infection... (Meta-Analysis)
Meta-Analysis Review
AIM
Pressure injuries (PIs) are one of the most common complications related to immobility, especially in hospitalized patients, which lead to increased morbidity, infection and overall decreased quality of life. Arginine supplementation may prevent the development of PIs. This study has summarized the findings of studies on the effect of arginine supplementation on PI healing.
DESIGN
Systematic review and meta-analysis.
METHODS
This study was conducted on online electronic databases including PubMed, Scopus, Web of Science, Google Scholar and Embase to identify relevant clinical trial studies up to September 2020. The pooled effect size of arginine supplement effects on PI was evaluated with standard mean difference (SMD) with 95% confidence interval (CI).
RESULTS
Eight studies met the inclusion criteria for this meta-analysis with 196 patients. PIs were significantly improved with Arginine supplementation (SMD: -0.6; CI 95%: -0.9 to -0.3, I : 72.5%, p = .001). Subgroup analysis showed that administering Arginine supplement more than 15 g/day had more beneficial effects on the healing of PIs (SMD: -2.8; CI 95%: -4.08 to -1.52, I : 54.7%, p = .138).
CONCLUSIONS
Our findings suggest that the administration of Arginine supplement in patients with PIs can accelerate the healing of this type of ulcer. Arginine is a supplement, and primary treatment is still needed to optimize PI healing. Therefore, arginine supplementation in addition to primary treatment seems to be an appropriate approach for the healing of PIs. Further well-designed studies are necessary to prevent the development of PIs compared to their primary treatment.
Topics: Humans; Arginine; Dietary Supplements; Enteral Nutrition; Quality of Life; Wound Healing; Pressure Ulcer
PubMed: 34170617
DOI: 10.1002/nop2.974 -
Journal of Pharmacy Practice Apr 2023As people age, they become increasingly vulnerable to the untoward effects of medicines due to changes in body systems. These may result in medicines related problems... (Review)
Review
BACKGROUND
As people age, they become increasingly vulnerable to the untoward effects of medicines due to changes in body systems. These may result in medicines related problems (MRPs) and consequent decline or deterioration in health.
AIM
To identify MRPs, indicators of deterioration associated with these MRPs, and preventative interventions from the literature.
DESIGN AND SETTING
Systematic review of primary studies on MRPs originating in Primary Care in older people.
METHODS
Relevant studies published between 2001 and April 2018 were obtained from Medline (via PubMed), CINAHL, Embase, Psych Info, PASCAL, Scopus, Cochrane Library, Science Direct, and Zetoc. Falls, delirium, pressure ulcer, hospitalization, use of health services and death were agreed indicators of deterioration. The methodological quality of included studies was assessed using the Down and Black tool.
RESULTS
There were 1858 articles retrieved from the data bases. Out of these, 21 full text articles met inclusion criteria for the review. MRPs identified were medication error, potentially inappropriate medicines, adverse drug reaction and non-adherence. These were associated with indicators of deterioration. Interventions that involved doctors, pharmacists and patients in planning and implementation yielded benefits in halting MRPs.
CONCLUSION
This Systematic review summarizes MRPs and associated indicators of deterioration. Appropriate interventions appeared to be effective against certain MRPs and their consequences. Further studies to explore deterioration presented in this systematic review is imperative.
Topics: Humans; Aged; Drug-Related Side Effects and Adverse Reactions; Medication Errors; Pharmacists; Physicians; Primary Health Care
PubMed: 34159813
DOI: 10.1177/08971900211023638 -
International Wound Journal Feb 2022Mucous membrane pressure injury (MMPI) is associated with a history of medical device use at the site of injury. The current international guideline recommends they...
Mucous membrane pressure injury (MMPI) is associated with a history of medical device use at the site of injury. The current international guideline recommends they should be reported in incidence and prevalence studies. The aim of this systematic review was to analyse the incidence and prevalence of hospital-acquired MMPI in adults admitted to acute hospital settings. Database searches (EBSCO CINAHL Complete, EBSCO Medline Complete, Embase, Scopus and Web of Science) were undertaken between October 2019 and February 2021, using search terms related to hospital-acquired, mucosal and device-related pressure injury/ulcer incidence and prevalence. Searches were limited to the English language. Articles published between 2008 and 2020, reporting incidence or prevalence of mucous membrane or medical device-related pressure injury in non-interventional samples were selected. Two authors assessed study bias and extracted data, with a third reviewer as arbitrator. Twenty-one studies met inclusion criteria; most provided incidence data. No studies were found that specifically reported MMPI incidence or prevalence. It was possible to calculate incidence or prevalence from four studies; all were in intensive care settings. MMPI incidence of 0.8% and 30.4%, and prevalence of 1.7% and 3.7% were found. One study provided data that enabled calculation of prevalence of 0.1% in a non-intensive care sample. Only one other study provided specific data about MMPI. It is concluded that there is insufficient evidence available to enable estimation of MMPI incidence or prevalence in either acute hospital or intensive care settings.
Topics: Adult; Hospitals; Humans; Incidence; Mucous Membrane; Pressure Ulcer; Prevalence
PubMed: 34128339
DOI: 10.1111/iwj.13629 -
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 Cochrane Database of Systematic... May 2021Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers.
OBJECTIVES
To assess the effects of non-foam and non-air-filled reactive beds, mattresses or overlays compared with any other 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 non-foam or non-air-filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used.
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 non-foam or non-air-filled 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 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias.
PRIMARY OUTCOME
Pressure ulcer incidence We did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I = 0%; low-certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty. Included studies did not report time to pressure ulcer incidence for any comparison in this review. Secondary outcomes Support-surface-associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low-certainty evidence). All reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low-certainty evidence). We did not find any health-related quality of life or cost-effectiveness evidence for any comparison in this review.
AUTHORS' CONCLUSIONS
Current evidence is generally uncertain about the differences between non-foam and non-air-filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health-related quality of life and cost-effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds. 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 adjudicators of the photographs being blinded to group allocation. Further review using network meta-analysis will add to the findings reported here.
Topics: Adult; Aged; Aged, 80 and over; Bedding and Linens; Beds; Bias; Elasticity; Humans; Incidence; Middle Aged; Pressure Ulcer; Randomized Controlled Trials as Topic; Viscoelastic Substances; Water
PubMed: 34097764
DOI: 10.1002/14651858.CD013623.pub2 -
The Cochrane Database of Systematic... May 2021Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive air surfaces (beds, mattresses or overlays) can be used for preventing pressure ulcers.
OBJECTIVES
To assess the effects of reactive air 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 reactive air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for preventing pressure ulcers.
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 reactive air surface was compared with surfaces that were not clearly specified, then we recorded and described the concerned study but did not included it in further data analyses.
MAIN RESULTS
We included 17 studies (2604 participants) in this review. Most studies were small (median study sample size: 83 participants). The average participant age ranged from 56 to 87 years (median: 72 years). Participants were recruited from a wide range of care settings with the majority being acute care settings. Almost all studies were conducted in the regions of Europe and America. Of the 17 included studies, two (223 participants) compared reactive air surfaces with surfaces that were not well described and therefore could not be classified. We analysed data for five comparisons: reactive air surfaces compared with (1) alternating pressure (active) air surfaces (seven studies with 1728 participants), (2) foam surfaces (four studies with 229 participants), (3) reactive water surfaces (one study with 37 participants), (4) reactive gel surfaces (one study with 66 participants), and (5) another type of reactive air surface (two studies with 223 participants). Of the 17 studies, seven (41.2%) presented findings which were considered at high overall risk of bias.
PRIMARY OUTCOME
Pressure ulcer incidence Reactive air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.42; 95% confidence interval (CI) 0.18 to 0.96; I = 25%; 4 studies, 229 participants; low-certainty evidence). It is uncertain if there is a difference in the proportions of participants developing a new pressure ulcer on reactive air surfaces compared with: alternating pressure (active) air surfaces (6 studies, 1648 participants); reactive water surfaces (1 study, 37 participants); reactive gel surfaces (1 study, 66 participants), or another type of reactive air surface (2 studies, 223 participants). Evidence for all these comparisons is of very low certainty. Included studies have data on time to pressure ulcer incidence for two comparisons. When time to pressure ulcer incidence is considered using a hazard ratio (HR), low-certainty evidence suggests that in the nursing home setting, people on reactive air surfaces may be less likely to develop a new pressure ulcer over 14 days' of follow-up than people on alternating pressure (active) air surfaces (HR 0.44; 95% CI 0.21 to 0.96; 1 study, 308 participants). It is uncertain if there is a difference in the hazard of developing new pressure ulcers between two types of reactive air surfaces (1 study, 123 participants; very low-certainty evidence). Secondary outcomes Support-surface-associated patient comfort: the included studies have data on this outcome for three comparisons. We could not pool any data as comfort outcome measures differed between included studies; therefore a narrative summary is provided. It is uncertain if there is a difference in patient comfort responses between reactive air surfaces and foam surfaces over the top of an alternating pressure (active) air surfaces (1 study, 72 participants), and between those using reactive air surfaces and those using alternating pressure (active) air surfaces (4 studies, 1364 participants). Evidence for these two comparisons is of very low certainty. It is also uncertain if there is a difference in patient comfort responses between two types of reactive air surfaces (1 study, 84 participants; low-certainty evidence). All reported adverse events: there were data on this outcome for one comparison: it is uncertain if there is a difference in adverse events between reactive air surfaces and foam surfaces (1 study, 72 participants; very low-certainty evidence). The included studies have no data for health-related quality of life and cost-effectiveness for all five comparisons.
AUTHORS' CONCLUSIONS
Current evidence is uncertain regarding any differences in the relative effects of reactive air surfaces on ulcer incidence and patient comfort, when compared with reactive water surfaces, reactive gel surfaces, or another type of reactive air surface. Using reactive air surfaces may reduce the risk of developing new pressure ulcers compared with using foam surfaces. Also, using reactive air surfaces may reduce the risk of developing new pressure ulcers within 14 days compared with alternating pressure (active) air surfaces in people in a nursing home setting. 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 adjudicators of the photographs being blinded 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; Elasticity; Humans; Middle Aged; Pressure Ulcer; Randomized Controlled Trials as Topic; Viscoelastic Substances; Water
PubMed: 33999463
DOI: 10.1002/14651858.CD013622.pub2