Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-07-31

Brief Summary

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The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

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Detailed Description

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Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.

Conditions

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mepilex® Border

If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention

Group Type EXPERIMENTAL

Mepilex® Border Sacrum and Mepilex® Border Heel

Intervention Type DEVICE

Control

Standard pressure ulcer prevention according to hospital standard

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mepilex® Border Sacrum and Mepilex® Border Heel

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
* Being at "high" or "very high" PU risk according to the Charité PU prevention standard:

\- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
* Expected minimum length of stay at least three days
* Informed consent (or by legal representative)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No