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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-09

Study Completion Date

2017-05-04

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

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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.

Conditions

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Pressure Incidence Prevention

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A. Mepilex Border Sacrum (Safetac)

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).

Group Type EXPERIMENTAL

Mepilex Border

Intervention Type DEVICE

Multi-layer Foam Dressings

B. Mepilex Border Heel (Safetac)

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).

Group Type EXPERIMENTAL

Mepilex Border

Intervention Type DEVICE

Multi-layer Foam Dressings

Interventions

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Mepilex Border

Multi-layer Foam Dressings

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No