Aims: To assess the performance of ALLEVYN Gentle Border in the management of a range of wounds including pressure ulcers, venous ulcers, diabetic ulcers, burns, donor sites, fungating/malignant wounds and surgically dehisced wounds in a variety of clinical settings. The primary objective was to assess the overall clinical acceptability for the indications treated. Secondary objectives included assessing dressing performance characteristics, determining changes in wound outcomes over the course of treatment, and clinicians’ level of satisfaction with product characteristics.
Methods: A multi-centre clinical evaluation conducted in 2008.
Results: 153 adult patients were recruited from six countries. A total of 45% of patients (69/153) completed the study period (4–6 dressing change assessments) and 33% (51/153) of patients’ wounds had healed before the end of the study period. Clinicians found the dressing to be suitable for the wound type treated in 95% (145/152) of patients. There was significant evidence of a reduction in wound area and depth by the final assessment (p<0.001); the median reduction in wound area and depth was 69% and 63%, respectively. There was significant evidence of a reduction in the level of exudate by the final assessment (p<0.001) although 87% of the study group had lightly or moderately exuding wounds at the beginning of the study. No pain at dressing removal was reported for 93% of removals.
Conclusions: The new silicone adhesive hydrocellular foam dressing was effective in improving wound outcomes in conjunction with routine clinical practice.
Conflict of interest: This study was carried out by Smith & Nephew as part of an in-market evaluation.