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

Not Applicable

Completed

• Conditions: Pressure Injury Prevention
• Interventions: Device: Biatain Silicone Sacral dressing

• Registration Number: NCT05619003
• Lead Sponsor: Coloplast A/S

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.

Study Timeline

• Study Start: 2022-08-26
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-16
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	Biatain Silicone Sacral dressing	The clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center investigation

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	25th August - 8th December 2022	Evaluate the safety of Biatain Silicone Sacral

Secondary Outcome Measures

Name	Time	Method
Number of Device Deficiencies	25th August - 8th December 2022	Evaluate the safety of Biatain Silicone Sacral

Trial Locations

Locations (3)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark

Herlev Hospital; 🇩🇰 Copenhagen, Denmark