Multi-centre, Non-comparative Clinical In-Market Evaluation of a Silicone adhesive hydrocellular foam dressing*

Objective: The primary objective was to assess overall acceptability of the dressings for their indicated uses.  Secondary objectives were to assess the dressing in terms of retention, performance characteristics and change in wound condition over a maximum of 6 dressing changes.

 

Methodology: This study was a multi-centre, non-comparative Clinical In-Market Evaluation.  A total of 153 patients were recruited across 72 centres in UK, Ireland, Holland, Germany, Spain and Canada during the study period of March to November 2008. 

Results: The mean age of the 153 patients was 73 years (range of 22 to 99 years) of which 37.5% were male and 62.5% female.  Treatment settings included hospital (36%), home (18%), wound clinic (37%), nursing home (7%) and other (3%).  The median reference wound duration was 3 weeks (range of 0.1 weeks to 50 years). Clinician’s rated the dressing as acceptable for the indication treated in 95% of patients (145/152). There was significant evidence of a reduction in the reference wound area over all patients (p<0.001), with a median reduction at the final assessment of 69%. There was significant evidence of a reduction in the level of exudate in the reference wound between baseline and the final assessment (p<0.001). There was no reported pain on removal of the dressing in 93% of dressing removals.

Conclusion: The silicone adhesive hydrocellular foam dressing*  was shown to be an effective dressing in conjunction with routine clinical practice in improving wound outcomes, in particular reducing wound area, depth and level of exudate.