NCT05619003

Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Injury Prevention

Interventions

Type	Name	Description
DEVICE	Biatain Silicone Sacral dressing	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

Timeline

• Start date: 2022-08-15
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2022-11-16
• Last updated: 2025-09-10
• Results posted: 2025-09-10

Locations

3 sites across 1 country: Denmark