Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT05619003
Brief 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.
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:
NCT05619003
Study Brief:
Protocol Section:
NCT05619003