A Phase 4 interventional study of Mepilex® Border dressing and Standard care in Pressure Ulcers, Prevention and Skin Ulcer, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Prevention
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.
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.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's planned enrollment of 478 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pressure ulcer prevention standard care
Other: Standard care
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Combination Product: Mepilex® Border dressing · Other: Standard care
Soft silicone self-adherent dressing (5-layers)
The control group will receive pressure ulcer prevention standard care
Pressure ulcer incidence
Incidence of sacral pressure ulcers acquired during patients' hospital stay
Time frame: 0-20 days
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand