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Post-market clinical evaluation of the safety and performance of ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite dressings

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Post-market clinical evaluation of the safety and performance of ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite dressings

Rachel Burns, Rebecca Forder
27 September 2020

This post-market evaluation assessed the performance of the ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite dressings and gathered feedback from clinicians using both dressings to treat a variety of wounds. The primary outcomes were progression to healing through management of exudate and maintenance of a moist wound healing environment. The evaluation took place at 1 site within Poland, where 53 patients were treated according to ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite dressings’ instructions for use, and standard local practice. Data was collected at every dressing change. The results showed that both ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite Dressings had positive effects on exudate levels, periwound condition and tissue type(s) within the wound bed. The majority of wounds reduced in size during the evaluation period and twelve completely healed. Clinical and patient satisfaction was high. No adverse events were reported. The evaluation shows ActivHeal® Silicone Foam and ActivHeal® Silicone Foam Lite Dressings used in clinical practice are safe, effective and acceptable for use to both practitioners and patients.

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