An open, prospective, non-comparative clinical in-market evaluation of a soft gel adhesive hydrocelluar foam dressing*

Introduction: Proper wound fluid management is key in the management of a wound. The purpose of this study is to evaluate a hydroellular foam with a silicone adhesive for a variety of parameters on wide range of wound types including DFUs.

Materials/Methods: n=56, an open, prospective, non-comparative clinical in-market evaluation across 29 centres in UK, Ireland,Holland, Germany and Spain during the study period of March to September 2008. Primary objective: To assess overall acceptability of the soft gel adhesive hydrocelluar foam dressings* for the indicated uses. A variety of Secondary objectives were also addressed.

Results: In a total of 21% (12) of patients, the reference wound closed, over a median duration of 17 days. There was significant evidence of a reduction in reference wound area over all patients (p<0.001), with a median reduction at the final assessment of 57.9%. There was also significant evidence of a reduction in wound area by the final assessment in both acute and chronic wounds (p<0.001 for both wound types, median reduction of 65.2% in acute wounds and 50.3% in chronic wounds).

Conclusion: For the primary objective of the study the clinicians rated the soft gel adhesive hydrocelluar foam dressing* as acceptable in 95% of patients treated. The majority of clinicians rated the soft gel adhesive hydrocelluar foam dressings* as exceeding or satisfying their expectations with regard to exudate management, ease of use, pain on removal, trauma to wound/surrounding skin, patient comfort and convenience.