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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Pressure Ulcers, Prevention, Skin Ulcer, Ulcer

Intervention / Treatment
-----------------
* Combination Product: Mepilex® Border dressing
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard care<br>pressure ulcer prevention standard care | Other: Standard care<br>* The control group will receive pressure ulcer prevention standard care<br>|
| Experimental: standard care + Mepilex® Border<br>pressure ulcer prevention standard care + Mepilex® Border applied on sacrum | Combination Product: Mepilex® Border dressing<br>* Soft silicone self-adherent dressing (5-layers)<br>Other: Standard care<br>* The control group will receive pressure ulcer prevention standard care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcer incidence | Incidence of sacral pressure ulcers acquired during patients' hospital stay | 0-20 days |