Prevention of Sacral Pressure Ulcers With Preventive Dressings

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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Key information

Conditions

Grade I to Grade IV Pressure Ulcers in Higher Risk Patients Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Hospital of Maastricht

Maastricht, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepilex® Border Sacrum dressings

Device

Mepilex® Border Sacrum dressings

Primary outcomes

To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).

Time frame: 8 weeks

till hospital release, max 8 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: SACRESS

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 13, 2012
Registry last updated: Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed