CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Biatain Silicone Sacral dressingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05619003
NCT05619003N/ACompleted

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

Coloplast A/S·interventional·Posted Nov 16, 2022·Updated May 29, 2026

In Brief

A clinical study evaluating Biatain Silicone Sacral dressing for Pressure Injury Prevention. Completed, enrolled 67 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 16, 2022
Enrollment StartAug 15, 2022
Primary CompletionDec 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.6 years ago

Interventions

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