Methodology: A total of 126 patients were evaluated from 24 centers (16 USA, 8 EU) during the period October 2007 to March 2008. Patients were recruited from the adult (≥18 years) populations routinely seen by the evaluation clinicians from across the UK, Spain, Ireland, France, Germany and USA.
Primary objective was to determine whether the dressings are acceptable to clinicians for their indicated uses. Secondary objectives included assessment for a variety of performance parameters, to assess any wound changes over the dressing changes conducted, and to determine whether the clinicians were sufficiently satisfied with the performance of the product overall.
Key results: Clinicians assessed the overall acceptability for 111 patients. The dressings were rated as acceptable for the majority of patients (88%) and wound types. For the majority of patients, clinicians rated the evaluation dressings as satisfactory or exceeding expectations with regards to all aspects of dressinf use. Of the 659 dressing applications applied to 126 patients, there were only five product complaints over the duration of the evaluation (0.8% of dressing applications). This equates to a low level of product complaints in terms of exposure and suggests no concerns with the safety of the evaluation products.
Conclusion: The dressings were rated as acceptable across the indications treated and the majority of dressings were fully adhered prior to removal. There was significant evidence of a reduction in the wound area from initial to final assessment. Data from on the primary and secondary objectives indicates that the dressing was acceptable to the majority of clinicians/patients.