- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823963
Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery (MEPICARD)
A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
-
Principal Investigator:
- Franck HENTZ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject over 18 years of age,
- Subject programmed to benefit from cardiac surgery with sternotomy,
- Subject capable and willing to comply with the protocol and willing to give his written consent,
- Subject affiliated to a social security system
Exclusion Criteria:
- Subject with a skin lesion in the sacral area upon admission,
- Subject admitted for emergency cardiovascular surgery (unscheduled subject),
- Subject admitted for heart transplant surgery,
- Subject participating in another clinical study or in a period of exclusion from a study previous,
- Subject with a linguistic or psychological disability to sign informed consent,
- Subject refusing to give written consent,
- Subject deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard care
pressure ulcer prevention standard care
|
The control group will receive pressure ulcer prevention standard care
|
Experimental: standard care + Mepilex® Border
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
|
The control group will receive pressure ulcer prevention standard care
Soft silicone self-adherent dressing (5-layers)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure ulcer incidence
Time Frame: 0-20 days
|
Incidence of sacral pressure ulcers acquired during patients' hospital stay
|
0-20 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Franck HENTZ, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-418
- 2018-A00694-51 (Other Identifier: 2018-A00694-51)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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