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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    1 Recommendations

    1.1

    There is not enough evidence to determine whether price variations between different antimicrobial agents in topical antimicrobial dressings for infected leg ulcers are justified. So, if an antimicrobial dressing is needed to treat an infected leg ulcer, use the least expensive option that is:

    • clinically appropriate, and

    • meets the preferences and needs of the person with the infected leg ulcer.

    1.2

    A healthcare professional and the person with the leg ulcer should reach a joint decision on which dressing to use (see the NICE page on shared decision making). Decisions should take into account how the choice of dressing might impact the person's:

    • physical health

    • mental health and wellbeing

    • relationships with others

    • ability to complete activities of daily living.

    1.3

    When deciding on the least expensive option, consider the following factors:

    • the cost of the primary dressing

    • the need for and cost of additional products

    • the frequency of dressing changes needed

    • if a person can change their own dressing or if a visit by a healthcare professional is needed.

    What information is needed

    More information is needed to determine whether price variations between different antimicrobial agents in topical antimicrobial dressings can be justified. Evidence should compare agents with each other and in similar dressing types. Evidence should be statistically powered, report details of concomitant treatments and ideally be done in a community setting in the NHS.

    Key outcomes that should be captured include:

    • clinical performance outcomes of the dressings to evaluate clinical and cost effectiveness, including:

      • health-related quality of life

      • time taken to clear signs and symptoms of infection

      • time to complete wound healing

      • duration of antimicrobial dressing use and any other leg ulcer treatments

      • short- and long-term toxicity of the antimicrobial agents in the dressings

      • other adverse events or sensitivities to the dressing, including the number of people who have contraindications to particular antimicrobial agents

      • infection load and the type of bacteria killed or removed by the dressing

      • the number of people who progress to needing oral antibiotics

    • healthcare professional preferences, including:

      • dressing conformability

      • ease of application

      • ease of removal.

    What this means in practice

    Considerations for procurement and commissioning

    According to the National Wound Care Strategy Programme, in 2019 there were an estimated 739,000 leg ulcers in England with estimated associated healthcare costs of £3.1 billion per year. The focus of this assessment is the subset of leg ulcers with a local infection. The prevalence of infection in 2 UK-based studies was reported to be 18% (in leg ulcers of any cause) and 41% (in venous leg ulcers).

    Considerations for wound management formulary groups

    These recommendations are not intended to restrict choice. When developing a formulary, if dressings have similar technical specifications but different agents or prices, decision making should consider cost and the factors listed in recommendation 1.3.

    Information on the cost of dressings should be available to healthcare professionals so that they can decide, using the factors listed in recommendation 1.3, which of the clinically appropriate options is the least expensive.

    Considerations for healthcare professionals

    These recommendations do not replace clinical reasoning. If more than one type of dressing is clinically appropriate, the choice of dressing should be based on patient preferences and cost, taking into account the factors listed in recommendation 1.2 and 1.3.

    Considerations for people with infected leg ulcers

    People with infected leg ulcers should be involved when deciding which antimicrobial dressing to use. They should be given information on the antimicrobial dressing that is being prescribed and, where possible, offered options that meet their needs. They should be given support if they experience any issues and wish to change to another type of antimicrobial dressing.

    Why the committee made these recommendations

    There are many topical antimicrobial dressings available with a variety of antimicrobial agents, which vary in technical specification and cost. This assessment aimed to determine whether the differences in clinical, economic and non-clinical outcomes attributed to those antimicrobial agents could justify price variation.

    Given the uncertainties in the clinical evidence, it is not possible to say whether any antimicrobial agent works better than the others. These uncertainties include:

    • a lack of direct comparisons of antimicrobial agents

    • differences in:

      • the outcomes measured and

      • when the outcomes were measured.

    So it is not possible to say whether price differences are justified.

    A user preference assessment of healthcare professionals shows that there are multiple criteria that healthcare professionals consider when selecting antimicrobial dressings. These include a holistic assessment of the person's clinical and social needs. Healthcare professionals also consider criteria relating to the cost of the dressing and treatment of the leg ulcer. Once clinically appropriate dressings are identified, the decision on which to use should be based on cost and patient preference.

    Evidence shows that people with infected leg ulcers are often not involved in selecting their antimicrobial dressing. There are many personal factors that could be impacted by using an antimicrobial dressing and these should be discussed with the person when choosing a dressing.

    More evidence is needed to show whether price variations can be justified by differences in how well different antimicrobial dressings work. Evidence should be collected for outcomes that are important to the people using the dressings, and that allow clinical and cost benefits to be assessed.