NCT03823963

Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 478 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital. Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

Detailed description

The main objective of this research is to evaluate the impact of Mepilex Border® dressing applied in addition to standard pressure ulcer prevention protocol, in a French hospital setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation including block operation and ICU. Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate of sacral pressure ulcer development than patients receiving standard care.

Conditions

• Pressure Ulcers
• Prevention
• Skin Ulcer
• Ulcer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mepilex® Border dressing	Soft silicone self-adherent dressing (5-layers)
OTHER	Standard care	The control group will receive pressure ulcer prevention standard care

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-08-31
• Completion: 2020-01-31
• First posted: 2019-01-31
• Last updated: 2019-01-31

Locations

1 site across 1 country: France