Prevention of Sacral Pressure Ulcers With Preventive Dressings (SACRESS)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Treatments: Device: Mepilex® Border Sacrum dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT01640418

NL40299.068.12

Details and patient eligibility

About

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?

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

Mepilex® Border Sacrum dressings

Experimental group

Description:

Mepilex® Border Sacrum dressings

Treatment:

Device: Mepilex® Border Sacrum dressings

Standard Care

No Intervention group

Description:

Standard Care