N/A N=67 Prevention

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

Pressure Injury Prevention

Bottom Line

View on ClinicalTrials.gov: NCT05619003 ↗

Enrolled (actual)

Serious AEs

6.0%

Results posted

Sep 2025

Primary outcome: Primary: Number of Adverse Events — 0 Adverse events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Biatain Silicone Sacral dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	—	—
SECONDARY Number of Device Deficiencies	4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05619003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.