Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk (NCT05619003) | Clinical Trial Compass
CompletedNot Applicable
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
Denmark67 participantsStarted 2022-08-15
Plain-language summary
A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.
Who can participate
Age range18 Years
SexALL
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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