Prevention of Sacral Pressure Ulcers With Preventive Dressings

Not Applicable

Completed

• Conditions: Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
• Interventions: Device: Mepilex® Border Sacrum dressings

• Registration Number: NCT01640418
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-13
• Study Start: 2012-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex® Border Sacrum dressings	Mepilex® Border Sacrum dressings	Mepilex® Border Sacrum dressings

Primary Outcome Measures

Name	Time	Method
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).	8 weeks	till hospital release, max 8 weeks

Trial Locations

Locations (1)

Academic Hospital of Maastricht; 🇳🇱 Maastricht, Netherlands