Clinical trial NCT05619003: Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury Prevention
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center investigation.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 25th August - 8th December 2022
Secondary outcomes:
measure: Number of Device Deficiencies
timeFrame: 25th August - 8th December 2022
Other outcomes:
measure: Hospital-acquired sacral pressure injuries during investigation period (Yes/No)
timeFrame: 25th August - 8th December 2022
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Herlev Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Coloplast A/S
name: Christina Overgaard, SSM
role: STUDY_CHAIR
References: