Pressure Injury PreventionNCT05619003
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
A study testing Biatain Silicone Sacral dressing in people with Pressure Injury Prevention, run by Coloplast A/S at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury Prevention
- What is being tested?
- Biatain Silicone Sacral dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Aug 2022to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Bispebjerg Hospital
Copenhagen
Herlev Hospital
Copenhagen
Hvidovre Hospital
Copenhagen
About this study
Official title: 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.
Read the 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.
- Conditions
- Pressure Injury Prevention
- Being tested
- Biatain Silicone Sacral dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biatain Silicone Sacral dressingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Biatain Silicone Sacral Dressing | Experimental | Not described Receives: Device: Biatain Silicone Sacral dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (1)
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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start15 Aug 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure Injury PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Overgaard, SSM, Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619003
- Sponsor's protocol ID
- CP346
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2022
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05619003
- Acronym / sponsor ID
- CP346
- Conditions
- Pressure Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.
| Arm | Type | Receives |
|---|---|---|
| Biatain Silicone Sacral Dressing | Experimental | Device: Biatain Silicone Sacral dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biatain Silicone Sacral dressingBiatain 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 | Device | Biatain Silicone Sacral Dressing |
Primary outcome
Number of Adverse Events
Time frame: 7 days
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)
1 secondary outcome
Number of Device Deficiencies
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pressure Injury Prevention
Recruiting
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Spinal Cord Injury, Pressure Injury
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Not yet recruiting
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
Open Abdomen, Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Overgaard, SSM study chair
Coloplast A/S
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biatain Silicone Sacral dressing in people with Pressure Injury Prevention, run by Coloplast A/S at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.