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.

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.

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.

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.

Managing surgical wound care: review of Leukomed Control dressings.

Optimal management of surgical wounds is an important part of postoperative recovery. The aim of postoperative wound care is to facilitate rapid wound closure, while preventing complications and promoting minimal disturbance, to achieve the best functional and aesthetic results. Health professionals should seek to optimise the process of acute wound healing, observe progress, and prevent wound complications. Dressings that permit extended wear time, and are transparent and so allow early recognition without the need for unnecessary changes, have the potential to minimise the effect on patients and the wider health economy. This article reviews recommendations for surgical wound care, and introduces the recently launched Leukomed Control dressing that is entirely transparent and allows greater flexibility, breathability, and visualisation of the wound.

Wound-bed preparation: the importance of rapid and effective desloughing to promote healing.

This article describes effective ways of diagnosing and removing slough from a wound bed. It highlights how slough is a key contributor to wound chronicity, and gives practical clinical information on how to address this. The various methods of removing slough will be discussed including the mechanism of action of dressings and other mechanical methods. The ultimate objective of the article is to put the term desloughing on the clinical agenda and increase clinician familiarity with it. The practical focus of the article will help clinicians select a proven method to facilitate the rapid removal of slough, it is hoped that in doing so this will help to prevent chronicity, reduce the potential for bacterial proliferation and promote rapid and effective wound healing outcomes.

A pilot study exploring quality of life experienced by patients undergoing negative-pressure wound therapy as part of their wound care treatment compared to patients receiving standard wound care.

The use of negative pressure wound therapy (NPWT) has been widely documented as a technique to help heal complex wounds. This article presents the findings of a preliminary study which aimed to explore quality of life (QoL) experienced by patients undergoing NPWT as part of their wound care treatment in comparison to that of patients with a wound using traditional (standard) wound care therapies. A quasi-experimental study was undertaken, with patients treated in wound care/vascular clinics with chronic/acute wounds. QoL impact was measured using the Cardiff Wound Impact Schedule and administered post-consent at timed intervals. Our results identified that there were no real differences in QoL scores recorded by patients over the 12-week period. Although there was no overall interaction between the therapies used for wound healing, NPWT did have an effect on social life: during the first 2 weeks of the application of therapy, patients in the NPWT group reported an increase in the social life domain. The authors conclude that true QoL can only be elicited if an accurate baseline is established or if data is collected over a long enough period to allow comparison of scores over time.

Exploring portable negative pressure wound therapy devices in the community.

Case studies and clinical reviews support the use of negative pressure wound therapy (NPWT) for managing a range of wound types, yet very few scientific studies fully support its effectiveness. However, it has been argued that NPWT can provide excellent symptom management, reduce the frequency of dressing changes and provide a cost-effective alternative to traditional wound therapies due to faster healing times, leading to a reduction in overall treatment costs. Use of NPWT within community environments is increasing as length of hospital in-patient stay decreases, and many patients who would have traditionally been admitted to an acute setting with a complex or highly exuding wound are now managed by community nurses. This article presents a narrative review of NPWT, identifies safety precautions that require consideration and explores the application of smaller/disposable NPWT systems that are now available.

Venous leg ulcer management: single use negative pressure wound therapy.

A number of leg ulcer specialist/tissue viability specialists from across the UK were invited to evaluate PICO (Smith and Nephew, Hull) as a treatment for venous leg ulcers also in conjunction with a variety of compression bandages and garments. Patients across 5 sites had PICO applied in conjunction with compression therapy. This group of treating clinicians were then asked to give feedback on the outcome of the patients on whom they had used the new device. All feedback was recorded at a meeting and this was used to create a guideline for use.