Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral

Study Overview
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Brief Summary
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A prospective single-arm study investigating the safety of Biatain Silicone Sacral while used as prophylactic prevention amongst hospital admitted patients at risk of developing a pressure injury.

Detailed Description
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The Biatain Silicone Sacral and Multishape dressings are multi-layer polyurethane foam dressings. They are CE-marked products and have been on the US market since April 2018. They are evaluated as safe to use and perform according to their intended purpose and indications. This investigation is a Post-market Clinical Follow-up Study, which aims to support the clinical performance of Biatain Silicone Sacral regarding the use of the dressing as part of prophylactic therapy to help prevent skin damage, e.g. pressure injuries. A pressure injury (PI) or pres-sure ulcer (PU) is defined as localized damage to the skin and/or underlying tissue, as a result of pressure or pressure in combination with shear. PI's usually occur over a bony prominence, but may also be related to a medical device or other object. The need for follow-up clinical data regarding this indication has been suggested in the Clinical Evaluation for Bi-atain Silicone Sacral and Multishape, and an outline of investigation CP346 is described in the Post-market Clinical Follow-up section of the Clinical Evaluation Report (CER) VV-0247441 for Biatain Silicone Sacral and Multishape.

Official Title
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PIP 1.0 - Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral

Conditions
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Pressure Injury

Intervention / Treatment
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* Device: Biatain Silicone Sacral Bandage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm<br>The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation | Device: Biatain Silicone Sacral Bandage<br>* Biatain Silicone sacral will be applied on the sacral area as prevention of Pressure Ulcers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Examine the safety of Biatain Silicone Sacral | 25th August - 8th December 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Device Deficiencies | Examine the safety of Biatain Silicone Sacral | 25th August - 8th December 2022 |