Pressure Injury Prevention
Conditions
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.
Interventions
DEVICEBiatain 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
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Deficiencies | 7 days | Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged) |
Countries
Denmark
Contacts
STUDY_CHAIRChristina Overgaard, SSM
Coloplast A/S
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biatain Silicone Sacral Dressing Biatain Silicone Sacral will be applied over the bony prominence of the sacral area | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Biatain Silicone Sacral Dressing |
|---|---|
| Age, Continuous | 70.5 years |
| BMI | 27.4 kg/m2 |
| Braden Scale Score | 15.9 scores on a scale |
| Faecal incontinence | 12 Participants |
| Region of Enrollment Denmark | 66 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 27 Participants |
| Urinary incontinence | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 67 |
| other Total, other adverse events | 5 / 67 |
| serious Total, serious adverse events | 4 / 67 |
Outcome results
Primary
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)
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biatain Silicone Sacral Dressing | Number of Adverse Events | 0 Adverse events |
Secondary
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)
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biatain Silicone Sacral Dressing | Number of Device Deficiencies | 4 Device deficiencies |