NCT02295735

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

A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: PD Dr. Jan Kottner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Mepilex® Border Sacrum and Mepilex® Border Heel

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-11-20
• Last updated: 2020-07-02
• Results posted: 2020-07-02

Locations

1 site across 1 country: Germany