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

PD Dr. Jan Kottner

Status: Completed

Conditions: Pressure Ulcer

Treatments: Device: Mepilex® Border Sacrum and Mepilex® Border Heel

Study type: Interventional

Funder types: Other

Identifiers

NCT02295735

CRC-PU-A-16

Details and patient eligibility

About

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

Full description

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.

Enrollment: 475 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

Mepilex® Border

Experimental group

Description:

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

Treatment:

Device: Mepilex® Border Sacrum and Mepilex® Border Heel

Control

No Intervention group

Description:

Standard pressure ulcer prevention according to hospital standard