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

Not Applicable

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	7 days	Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged)

Secondary Outcome Measures

Name	Time	Method
Number of Device Deficiencies	7 days	Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged)

Locations (3): Bispebjerg Hospital
🇩🇰
Copenhagen, Denmark
Herlev Hospital
🇩🇰
Copenhagen, Denmark
Hvidovre Hospital
🇩🇰
Copenhagen, Denmark
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark