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.

Electrical stimulation for pain reduction in hard-to-heal wound healing.

OBJECTIVE: Despite treatment advances over the past 30 years, the societal impact of hard-to-heal wounds is increasingly burdensome. An unresolved issue is wound pain, which can make many treatments, such as compression in venous leg ulcers, intolerable. The aim of this review is to present the evidence and stimulate thinking on the use of electrical stimulation devices as a treatment technology with the potential to reduce pain, improve adherence and thus hard-to-heal wound outcomes. METHOD: A literature search was conducted for clinical studies up to August 2020 reporting the effects of electrical stimulation devices on wound pain. Devices evoking neuromuscular contraction or direct spinal cord stimulation were excluded. RESULTS: A total of seven publications (three non-comparative and four randomised trials) were identified with four studies reporting a rapid (within 14 days) reduction in hard-to-heal wound pain. Electrical stimulation is more widely known for accelerated healing and is one of the most evidence-based technologies in wound management, supported by numerous in vitro molecular studies, five meta-analyses, six systematic reviews and 30 randomised controlled trials (RCTs). Despite this wealth of supportive evidence, electrical stimulation has not yet been adopted into everyday practice. Some features of electrical stimulation devices may have hampered adoption in the past. CONCLUSION: As new, pocket-sized, portable devices allowing convenient patient treatment and better patient adherence become more widely available and studied in larger RCTs, the evidence to date suggests that electrical stimulation should be considered part of the treatment options to address the challenges of managing and treating painful hard-to-heal wounds.

Optimising resources: an evidence-based pathway using UrgoStart for community-based patients with wounds.

Providing a co-ordinated and strategic approach to the assessment, treatment and management of chronic wounds in healthcare is central to the provision of effective nursing practice and optimisation of resources in community nursing. This article describes a project conducted in Northumberland by a tissue viability team and a district nursing team to implement an evidence-based treatment pathway for patients with leg ulcers. It discusses the multiple positive benefits of this project-to the NHS, nursing staff and patients-and provides detailed information for other nursing teams to implement such a plan.

The characteristics and impact of hard-to-heal wounds: results of a standardised survey.

The effective management of hard-to-heal wounds has increasingly important implications for those who provide wound care services within healthcare systems. The burden of wounds in the population continues to grow, as does the demand for wound care, against a backdrop of cost constraints and increasing expectations. The need to improve both outcomes and efficiency in wound care is therefore paramount and the time taken to heal wounds is an important factor in determining both. Survey methodology was used to collect data across 10 community wound care providers in the UK, Ireland, Finland, Norway and Denmark between February and August 2017. This allowed for analysis of wounds and their characteristics, dressing selection and nursing practice across a typical wound caseload. Data from 1057 wounds demonstrates that the characteristics and consequences of hard-to-heal wounds are different from improving wounds. However, wounds are, in general, treated in the same way, irrespective of whether they are hard-to-heal or improving, suggesting that the healing status of a wound is not a major factor in treatment selection. Early intervention to return hard-to-heal wounds to a healing trajectory may be a useful approach to improving efficiency in wound care.

A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries.

This study aimed to evaluate the sensitivity and specificity of subepidermal moisture (SEM), a biomarker employed for early detection of pressure injuries (PI), compared to the "Gold Standard" of clinical skin and tissue assessment (STA), and to characterize the timing of SEM changes relative to the diagnosis of a PI. This blinded, longitudinal, prospective clinical study enrolled 189 patients (n = 182 in intent-to-treat [ITT]) at acute and post-acute sites (9 USA, 3 UK). Data were collected from patients' heels and sacrums using a biocapacitance measurement device beginning at admission and continuing for a minimum of 6 days to: (a) the patient developing a PI, (b) discharge from care, or (c) a maximum of 21 days. Standard of care clinical interventions prevailed, uninterrupted. Principal investigators oversaw the study at each site. Blinded Generalists gathered SEM data, and blinded Specialists diagnosed the presence or absence of PIs. Of the ITT population, 26.4% developed a PI during the study; 66.7% classified as Stage 1 injuries, 23% deep tissue injuries, the remaining being Stage 2 or Unstageable. Sensitivity was 87.5% (95% CI: 74.8%-95.3%) and specificity was 32.9% (95% CI: 28.3%-37.8%). Area under the receiver operating characteristic curve (AUC) was 0.6713 (95% CI 0.5969-0.7457, P < .001). SEM changes were observed 4.7 (± 2.4 days) earlier than diagnosis of a PI via STA alone. Latency between the SEM biomarker and later onset of a PI, in combination with standard of care interventions administered to at-risk patients, may have confounded specificity. Aggregate SEM sensitivity and specificity and 67.13% AUC exceeded that of clinical judgment alone. While acknowledging specificity limitations, these data suggest that SEM biocapacitance measures can complement STAs, facilitate earlier identification of the risk of specific anatomies developing PIs, and inform earlier anatomy-specific intervention decisions than STAs alone. Future work should include cost-consequence analyses of SEM informed interventions.

Implementation of NICE technology guidance on venous leg ulcers and diabetic foot ulcers: a conference report.

Implementation of evidence-based care is central to achieving good results. In the UK, this involves implementing guidance from the National Institute for Health and Care Excellence (NICE). Here, Tracy Cowan, JWC consultant editor, reports on a conference that outlined recently published NICE guidance on UrgoStart for treating leg ulcers and diabetic foot ulcers, and described how to incorporate this into everyday practice to drive significant cost savings and improve patient outcomes.