Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings

Study Overview
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Brief Summary
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A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit

Detailed Description
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This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.

Official Title
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A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit

Conditions
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Pressure Incidence Prevention

Intervention / Treatment
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* Device: Mepilex Border


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at risk for developing a pressure injury to the heels and/or sacrum Aged ≥ 18 years Patient or his/her legal representative is able to understand and voluntarily sign the informed consent Estimated treatment period in ICU for patient at least 4-6 days Exclusion Criteria: Patient has a pressure injury or blistering on sacrum and/or heels Patient with known or suspected sensitivity to any of the components of the products being evaluated Patient included in other clinical investigations at present or within the last 30 days

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. Mepilex Border Sacrum (Safetac)<br>A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI). | Device: Mepilex Border<br>* Multi-layer Foam Dressings<br>|
| Experimental: B. Mepilex Border Heel (Safetac)<br>A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI). | Device: Mepilex Border<br>* Multi-layer Foam Dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | 4-6 days | 
| User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication | User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? *NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections). | 4-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wear Time (Days) for First Dressing | Maximum length of wear time/stay on ability of dressings in ICU. | 4-6 days |