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

A Prospective Single-arm Study Investigating the Safety of Biatain Silicone Sacral While Used as Prevention in Hospital-admitted Patients at Risk of Developing a Pressure Injury

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury Prevention
• Intervention / Treatment: Device: Biatain Silicone Sacral dressing

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Bispebjerg Hospital
  • Copenhagen, Denmark
    • Herlev Hospital
  • Copenhagen, Denmark
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biatain Silicone Sacral Dressing	Device: Biatain Silicone Sacral dressing; Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area as part of a PIP (Pressure Injury Prevention) protocol in patients at risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	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)	7 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-acquired sacral pressure injuries during investigation period (Yes/No)	Evaluating the pressure injury prevention performance of Biatain Silicone Sacral when used as part of a PIP protocol	25th August - 8th December 2022

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Chair: Christina Overgaard, SSM, Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Crush Injuries
• Other Study ID Numbers: CP346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No