New dressing aims to prevent painful bedsores in hospital patients
NCT ID NCT05619003
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the safety of a special silicone dressing placed on the lower back of hospital patients at risk for pressure injuries (bedsores). 67 adults took part, and the dressing was used as part of a standard prevention plan for up to 7 days. The main goal was to see if the dressing caused any side effects or device problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biatain Silicone Sacral dressing (a silicone foam dressing applied to the lower back)
- What this could lead to
- If successful, this dressing could become a standard, safe tool to prevent painful pressure injuries in hospitalized patients.
- What could go wrong
- This is a small, single-arm safety study with no comparison group. It only looked at short-term safety (up to 7 days), not whether the dressing actually prevents injuries better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
67 people
The number who actually took part.
- Started
-
Aug 2022
- Finished
-
Dec 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Bispebjerg Hospital
Copenhagen, Denmark
-
Herlev Hospital
Copenhagen, Denmark
-
Hvidovre Hospital
Copenhagen, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- AI-Powered lessons could help nurses prevent bedsores
- Simple dressing may prevent painful mouth sores in ICU patients
- Color-Coded bedside cards aim to stop pressure injuries in their tracks
- New mattress aims to prevent bedsores without manual turning