Prevention of Sacral Pressure Ulcers With Preventive Dressings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?

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Detailed Description

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Conditions

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Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mepilex® Border Sacrum dressings

Group Type EXPERIMENTAL

Mepilex® Border Sacrum dressings

Intervention Type DEVICE

Mepilex® Border Sacrum dressings

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mepilex® Border Sacrum dressings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: ≥18 years
* Admission in one of the ten high-risk departments of the azM
* Suspected hospital stay of 5 days or more after admission
* Braden score 19 or less

Exclusion Criteria

* Age: \<18 years
* Pre-existing sacral pressure ulcer
* Pre-existing trauma to the sacrum
* Patient is unable to speak Dutch
* Patients with an inability to give informed consent
* Patients who are unable to give informed consent within 24h after admission
* Patients who are unable to give informed consent before surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No