Evaluation process of HydroClean plus.

A multi-centre product evaluation of HydroClean plus was undertaken on patients who were routinely seen by three clinical services in the UK. Patients with acute or chronic wounds that contained devitalised tissue (necrosis and/or slough) in the wound bed were deemed suitable for treatment with HydroClean plus. The principles of research governance were observed, where all local procedures for ethical approval were followed within each facility before the evaluation started. Basic ethical principles, such as informed consent and maintaining patient confidentiality, were undertaken as identified in the Declaration of Helsinki[25]. Patients were recruited from the adult (≥18 years) population from within two specialist wound care services, and a community-based podiatry service that treats ‘at risk’ feet and regularly manages foot ulcers in patients with medical conditions, such as rheumatoid arthritis and diabetes, which are complex and challenging to manage. The study design required that the dressing was evaluated within ‘standard’ practice, and as such no other changes to care delivery would be made. The primary objective was to evaluate HydroClean plus dressing in facilitating woundbed preparation and wound progression in acute and chronic wounds. Of particular interest was the ability of the autolytic debridement action of the dressing to quickly and safely remove slough and necrosis to facilitate healing. The secondary objectives were to evaluate how the dressing performed when used in routine wound care, in particular the ease of application and removal, and whether the dressing was acceptable to both the patient and clinician. It was also important to undertake a simple economic evaluation to establish whether there was the potential for cost savings. Wound healing was observed as 100% epithelialisation of the wound. Total debridement was identified as 100% granulation tissue in the wound bed. The threshold of was used as a measure of clinical efficacy in a review by the National Institute for Health and Care Excellence[26]. The wound aetiology, size, location, duration, exudate level, wound-bed status and periwound skin condition were also documented. The patient’s pain related to the wound was established at baseline through the use of a visual analogue scale. Any wound care products used immediately before the use of HydroClean plus were also recorded. The wound outcomes were assessed and recorded at each dressing change, using basic techniques that are reflective of routine practice. At each dressing change, the wound size (area and depth) was recorded to demonstrate wound progression. The area was estimated by measuring the maximum length and width of the wound, then multiplying this figure to give the area in cm2 . Any pain associated with application, during wear or the removal of HydroClean plus was established using the visual analogue scale, and was also documented.