Using a prognostic medical device for early identification of pressure ulcers: protocol for study design.

BACKGROUND: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. AIM: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. METHOD: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. RESULTS: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. CONCLUSION: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.

The (dis)organization of leg ulcer care: A realist synthesis.

BACKGROUND: Venous leg ulcers affect 1.5% of the UK adult population. Leg ulcers are painful, can be malodourous and are associated with poor quality of life. Leg ulcers are predominantly cared for by nurses in the community. Frequently, patients receive suboptimal treatment through unwanted variations in care and simple ulcers deteriorate to become hard-to-heal wounds. It is important to understand the current UK system of care and how nurses and patients navigate through it. AIM: The aim of this paper was to understand how, when, for whom and in what context leg ulcers are cared for in the United Kingdom and specifically, the current system of care, the nurses' role and the patients' experience in this system of care. DESIGN: A realist synthesis of the literature was undertaken, reported following the RAMESES publication standards: Realist syntheses. DATA SOURCES: An iterative literature search was conducted across three recognized health collections from January 2010 to January 2022 that included descriptive studies as well as primary research. RESULTS: 73 papers were included. CONCLUSION: In the absence of UK national guidance that recommends how leg ulcer care is organized and delivered, care is commissioned locally, with variable outcomes. Patients with venous leg ulcers would like to be looked after by knowledgeable, skilled and confident nurses, in well-equipped and staffed clinics; nurses who have the ability to make clinical judgements to alter their treatment when necessary and are empowered to refer to specialist centres when further support is required. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: This synthesis offers guidance to commissioners and providers to change how leg ulcer care is organized. PATIENT OR PUBLIC CONTRIBUTION: The views of a patient and public group was sought at each stage of the synthesis.

A review of leg ulcerations coverage in the United Kingdom print media: A growing problem for the vulnerable adult.

It is estimated that venous leg ulcers affect 1-1.5% of the industrialised world's population. These can be painful, malodorous and debilitating to the person affected. In this paper we explore, through an analysis of the print media, how journalists translate medical knowledge into lay language and how they represent new directions in treatment. We also show how the term 'leg ulcer' is used as part of the description of vulnerable people at the edge of society, some whom are to be seen as needing our compassion, others as (morally) problematic. Finally, we show how stories around 'leg ulcers' are also used in relation to narratives around austerity in the UK and to show gaps in health and social care. We conclude that journalists, wound care researchers and health professionals should work together to inform the public and persons affected that leg ulceration can be successfully treated.

Dressings and topical agents for arterial leg ulcers.

BACKGROUND: It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003. OBJECTIVES: To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

Viewing dressing evaluation through a pragmatic lens: The application of Dewey's experimentalism in the development of evidence for dressing selection.

RATIONALE, AIMS, AND OBJECTIVES: The aim of this paper is to (1) summarize the challenges with developing evidence for dressing selection in wound care, (2) discuss the limiting influence that the Evidence-Based Practice movement has had in this field, and (3) discuss the opportunities offered by Dewey's theory of experimentalism as a pragmatic solution to develop a structured body of evidence. FINDINGS: Whilst the number of dressings available on the market continue to proliferate, limited progress has taken place to develop a methodology for dressing evaluation that is relevant to clinical practice. It is proposed that experimentalism can be operationalized with a mixed-methods approach that may include the following: (1) medical histories and patient's stories; (2) participant observation and informal interviews; (3) a comparative study between a new dressing and standard care; (4) a patient's satisfaction survey; (5) a staff survey; (6) a cost examination; (7) an evaluation of the packaging and procurement route; and finally (8) a clinical meeting to triangulate the data and reach a consensus. CONCLUSION: Experimentalism offers a framework for the construction of evidence used for dressing selection. Central to this concept is the integration of experience to the data collected. The context of the evaluation has equal weight to the data thus collected.

The provision of therapy mattresses for pressure ulcer prevention.

Preventing pressure ulcers is complex and involves skin care, the provision of therapy mattresses, repositioning, the management of incontinence and adequate nutritional support. This article describes a model of therapy mattress provision that is based on non-powered products. Evaluating the efficiency of this model is challenging, due to the complexities of care, but Safety Thermometer data and incidents reports offer reassurance that non-powered therapy mattresses can provide adequate pressure ulcer prevention. Therapy mattress provision is only one of the five interventions and these are described in details to give readers a fuller picture of the model used at the author's trust.

Dressings and topical agents for arterial leg ulcers.

BACKGROUND: It is estimated that people in industrialised countries have a 1% chance of suffering from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting the poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound care. Dressings and topical agents make up a part of good wound care for arterial ulcers but there are many products available and it is unclear what impact these have on ulcer healing. This is an update of a review first published in 2003. OBJECTIVES: To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates, patient-centred outcomes and costs between wound dressings and topical agents. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched November 2014) and The Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library) (2014, Issue 10). SELECTION CRITERIA: Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. The participants had to have ulcers that were described as arterial, and the time to healing, proportion completely healed, or rate of reduction in ulcer area had to be reported. All wound dressings and topical agents were eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: The two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Disagreements between the review authors were resolved through discussion. MAIN RESULTS: One trial met the inclusion criteria, which was a small trial that compared 2% ketanserin ointment in polyethylene glycol (PEG) with vehicle alone (PEG) control, changed twice a day in 40 participants with arterial leg ulcers. The overall quality of the evidence was low with a single small included study which showed inadequate reporting of the results and had too short a follow-up time (eight weeks) to be able to capture sufficient healing events to allow comparisons to be made. In addition, the study was of low methodological quality. The majority of the 'risk of bias' domains received an 'unclear' risk rating as very little information was provided in the text on the methods of the study. The trial demonstrated increased wound healing in the ketanserin group, compared with the control group, but the trial was too small and had too short a follow-up period (eight weeks) to be able to determine whether there was any difference in healing rates. It should also be noted that ketanserin is not licensed in all countries for use in humans. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

Best practice guidelines for the prevention and management of incontinence dermatitis.

This article outlines the causes of incontinence dermatitis and risk factors associated with this skin problem. The authors describe how simple guidance on skin care can improve patient care and use a case study to illustrate this.

Developing a workbook to support healthcare assistants in delivering competent care.

Ensuring that healthcare assistants are competent to perform tasks delegated to them is essential. The Newcastle upon Tyne Hospitals NHS Foundation Trust has developed a workbook that addresses competencies in continence (catheter care), nutrition and pressure ulcer prevention. The workbook aims to accompany clinical-based learning and help HCAs progress through the NHS Knowledge and Skills Framework. This article outlines issues around competence, and the three clinical areas covered in the workbook.

Is fluid filled mattress technology compatible with NICE guidance?

The NICE pressure ulcer guidelines the management of pressure ulcers in primary and secondary care (2005) recommend 'as a minimum provision a high specification foam mattress'. With this statement NICE infers that if quality of care is to be offered, an alternating pressure mattress should be used. In the Newcastle upon Tyne Hospitals NHS Foundation Trust, a new approach to pressure ulcer management has been pioneered, with the introduction of fluid-filled mattresses instead of alternating pressure technology. The Trust has moved to a 98.4% static approach, in effect questioning the NICE guidelines and its recommendations on the selection of appropriate pressure relieving surfaces. Quarterly studies demonstrate a reduction in the prevalence of pressure ulcers as well as significant savings being made, despite an initial financial outlay. The radical move from alternating pressure technology to fluid-filled static technology has been a success: will the same apply to primary care?

An online ordering system for therapy beds and mattresses.

Within this article, the authors have put forward a solution to keep track of pressure-relieving devices using internet-based secure online systems. In partnership with a therapy bed company they set up a system that was able to manage and monitor the requirements of their trust and ensure that products are used for patients who most need them. In using these systems they were also able to gather real-time data on usage and costs as well as time-dependent analysis. The system has also allowed a means of gathering outcome measurement of all products in use. Over a 6-month period the authors have shown how a forecasted 18% budget deficit has been turned into a 10% under spend of the overall budget. It is suggested that these systems could be one way of managing the pressure-relieving needs of hospital trusts ensuring both clinical effectiveness and cost-benefit.