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

Coloplast

Status: Completed

Conditions: Pressure Injury Prevention

Treatments: Device: Biatain Silicone Sacral dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT05619003

CP346

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Single-arm

Experimental group

Description:

The clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center investigation

Treatment:

Device: Biatain Silicone Sacral dressing