The cost of wound care continues to increase year-on-year. The NHS spent an estimated £5.3 billion on the management of wounds and related comorbidities in 2012/13 (Guest et al, 2017). It costs on average 135% more to treat chronic than acute wounds; therefore emphasis should be on identifying the reason for delayed healing, wound prevention and improving healing rates (Guest et al, 2017).

Exudate can hinder chronic wound healing as it: slows and may prevent cell proliferation; interferes with growth factor availability; and contains elevated levels of inflammatory mediators and activated matrix metalloproteinases (MMPs) that break down tissue (Mudge and Orsted, 2010; Romanelli et al, 2010). Effective management of exudate is a fundamental part of wound care.

Patients should receive a treatment plan to ensure a moist wound environment is maintained, the volume of exudate is managed with suitable dressings, the periwound skin is protected, and the cause of the wound or related factors are managed. This should reduce the healing time and subsequently improve the patients’ quality of life (Gardiner, 2012; World Union of Wound Healing Societies [WUWHS], 2019).

Excess exudate is a potential risk factor for infection (Adderley, 2008; Chadwick and McCardle, 2015). The presence of infection and devitalised tissue can result in malodour. Ineffectual handling of exudate can have a detrimental effect on both the wound and the patient — resulting in strikethrough, embarrassment, and damage to the surrounding skin, causing pain and discomfort. The practical, economic and social consequences for the patient can manifest as isolation from friends and family, the need to wash clothes more often and the use of cumbersome dressings that restrict movement and choice of clothing (Dowsett, 2012). It can be difficult to know which dressing to use to manage high levels of exudate. The ideal properties of such dressings include:

Patient and/or carer involvement should be considered when choosing a dressing, especially with the move towards self-care and patient empowerment. Patient and/or carer involvement can lead to improved concordance, an understanding of wound progression and an ability to make informed decisions relating to the wound management plan (International Best Practice Statement, 2016). For many patients, the ideal wound dressing is one that is not bulky, reduces the likelihood of pain during dressing change, needs fewer changes and is easy to apply and remove (Dowsett, 2012). Holistic assessment is vital to ensure the correct dressing is selected. This will facilitate faster healing, improve patient outcomes and quality of life (Nazarko, 2018; NICE, 2016).

Some dressing materials have the potential to alter the composition of exudate in ways that may prove beneficial to healing, therefore, possible interactions between the dressing and wound should be considered during the selection process.

Alginates

Alginate dressings have been in use for 2 decades and are primarily used to manage wound exudate. Alginate products are biocompatible, hydrophilic and biodegradable under normal physiological conditions. They form a soft gel on contact with exudate, providing a moist environment at the wound bed that promotes healing and epidermal regeneration (Timmons, 2009; Sood et al, 2014; Aderibigbe and Buyana, 2018).

Alginates have an inherent haemostatic effect and can be used to stop minor bleeding complications, for example after a wound biopsy (Naik and Harding, 2019). Alginate dressings contain alginic acid, usually derived from seaweed; the fibres contain mannuronic and guluronic acid and it is the combination (%) used which gives them the high tensile strength when wet (Naik and Harding, 2019).

Gelling Fibres

Fibre-based dressings are frequently selected due to their ease of use, effective exudate management and relatively low cost. Gelling fibres are structurally similar to alginates. Products containing gelling fibres are comfortable, easy to remove, and can be used with heavily exudating wounds. Together with their absorptive properties, gelling fibres promote tissue granulation and the maintenance of a moist wound environment (NHS Business Service Authority, 2018). They effectively remove MMPs and reduce bioburden due to their highly absorptive nature (Sood et al, 2012).

Cellulose is the most copious naturally occurring fibre with a high tensile strength (Waring and Parsons, 2001; Naik and Harding, 2019). It can be structurally altered to form carboxymethyl cellulose (CMC) on contact with fluids such as exudate. This characteristic helps CMC trap the fluid and components of exudate (e.g. MMPs), along with inflammatory cells, bacteria and debris, when used in gelling fibre dressings, locking them into the fibres and promoting autolytic debridement (Romanelli et al, 2010; Aderibigbe and Buyana, 2018; Naik and Harding, 2019). It is due to these properties that CMC-based dressings are widely used in clinical practice.

Figure 6. Exudate levels at the beginning and end of the evaluation period

The primary objective of the clinical evaluation was to assess the clinical safety and performance of Aquafiber® Extra in the management of acute and chronic wounds.

Method

Three sites in the UK participated in this product evaluation. Clinicians were provided with guidelines on the use of Aquafiber® Extra rather than being given a protocol to follow. The dressings were applied, when appropriate, in accordance with each site’s standard practice. Patients were followed up for a maximum of 6 weeks. Information was gathered on a range of patients and wounds. Clinical outcomes were observed and clinicians’ opinions of the dressing gathered.

Patients aged 18 or over and able to understand and give informed consent were eligible to participate. Patients were excluded if:

Clinicians were provided with a copy of the guidelines along with case report forms and patient consent forms. Patients were enrolled in the evaluation once they had provided informed consent. Participants were not randomised to treatment and no additional interventions were made to standard care; therefore, no ethical approval was required. Organisational consent was obtained for this study. ActivHeal® Aquafiber™ Extra was applied to wounds (leg ulcers, diabetic ulcers, pressure ulcers, post-operative surgical wounds and cavity wounds) that required debridement and a moist wound healing environment.

The primary outcomes of the evaluation were the progression to healing through exudate management and the maintenance of a moist wound environment. Wound size, tissue type(s) present in the wound bed, exudate levels, periwound condition and discomfort levels were measured. Ease of use, conformability to the wound, patient comfort during wear and removal, clinician satisfaction and the ability of Aquafiber® Extra to stay in place were evaluated in order to assess dressing performance.

Safety

There were no safety or adverse events reported during the evaluation. This suggests that for this particular evaluation there are no safety concerns with the use of ActivHeal® Aquafiber™ Extra dressing.

Discussion

The results of this post-market study are promising, with the use of ActivHeal® Aquafiber™ Extra resulting in positive healing outcomes in the majority of patients. The dressing was used to treat a variety of wounds, including leg ulcers, diabetic ulcers, pressure ulcers, post-operative surgical wounds and cavity wounds. ActivHeal® Aquafiber™ Extra maintained a moist wound environment and supported wound progression.

Wound size and depth improved over the study period. It was well tolerated by patients and clinician satisfaction with treatment was high overall. Data from the study support the use of ActivHeal® Aquafiber™ Extra dressing in a variety of wound types and clinical settings.

All the wounds treated had moderate to high levels of exudate at the start of the evaluation. Uncontrolled exudate can macerate periwound skin or even break it down (Adderley, 2008; Stephen- Haynes, 2011; Gardiner, 2012; WUWHS, 2019).

The reduction in observed levels of exudate and improvement in periwound skin during the evaluation period demonstrates that the dressing effectively absorbed exudate, which assists in preventing maceration. It has been widely reported in the literature that when the skin surrounding a wound is compromised, it can increase patient discomfort (WUWHS, 2019). The evaluation demonstrated that Aquafiber® Extra achieved high levels of comfort satisfaction.

Furthermore, the majority of dressing changes were performed to conduct routine wound assessment, rather than because of clinical need such as failure of the dressing to stay in place, leakage or strikethrough. This may have contributed to the high levels of patient satisfaction reported by clinicians. These factors added to the acceptability of the dressing for use in clinical practice and suggest this treatment has the potential to enhance patient comfort.

The results from this evaluation and in-vitro studies demonstrate the clinical effectiveness of this dressing with regards to clinical outcomes. The small number of clinicians who were dissatisfied with wound progression had possibly treated the wounds that did not progress towards healing and or the patients had other comorbidities that would affect progress during the evaluation period. The overall satisfaction levels reported by clinicians suggests that the use of ActivHeal® Aquafiber™ Extra is more than acceptable in practice.

Limitations

This evaluation included just 43 patients. Larger studies are needed to further explore whether the findings are related to the cohort or are applicable to all patients with wounds. Further studies are planned. Exudate levels are hard to assess and quantify. They can be subjective and are dependent on the judgement of the clinician assessing the wound (WUWHS, 2019).

Declaration of Interest

This article was supported by Advanced Medical Solutions.

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