N/A
Completed N=67
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
Pressure Injury Prevention
Source: ClinicalTrials.gov NCT05619003 ↗
Enrolled (actual)
67
Serious AEs
6.0%
Results posted
Sep 2025
Primary outcomePrimary: Number of Adverse Events — 0 Adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
— | — |
| SECONDARY Number of Device Deficiencies |
4 | — |
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
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. Informational only — not medical advice.