Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral (PIP)

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.

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.

The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation.

The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation

Examine the performance of Biatain Silicone Sacral, regarding its ability to help prevent pressure injuries.

Inclusion Criteria: Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1 ≥18 years of age and has full legal capacity Has given written consent to participate by signing the Informed Consent signature Form Has a Braden score of 6-18 at screening (performed within the last 24 hours) Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence) Exclusion Criteria: Suspected or actual spinal injury precluding the patient from being turned Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury Trauma to sacrum Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment) Pregnancy or breastfeeding