The Biatain Silicone Sacral and Multishape dressings are multi-layer polyurethane foam dressings. They are CE-marked products and have been on the US market since April 2018. They are evaluated as safe to use and perform according to their intended purpose and indications.~This investigation is a Post-market Clinical Follow-up Study, which aims to support the clinical performance of Biatain Silicone Sacral regarding the use of the dressing as part of prophylactic therapy to help prevent skin damage, e.g. pressure injuries. A pressure injury (PI) or pres-sure ulcer (PU) is defined as localized damage to the skin and/or underlying tissue, as a result of pressure or pressure in combination with shear. PI's usually occur over a bony prominence, but may also be related to a medical device or other object.~The need for follow-up clinical data regarding this indication has been suggested in the Clinical Evaluation for Bi-atain Silicone Sacral and Multishape, and an outline of investigation CP346 is described in the Post-market Clinical Follow-up section of the Clinical Evaluation Report (CER) VV-0247441 for Biatain Silicone Sacral and Multishape.
A prospective single-arm study investigating the safety of Biatain Silicone Sacral while used as prophylactic prevention amongst hospital admitted patients at risk of developing a pressure injury.