Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk

The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.

At daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.

There were no follow-up visits after termination of the study.

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