A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 478
- Locations
- 2
- Primary Endpoint
- Pressure ulcer incidence
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard care
pressure ulcer prevention standard care
Intervention: Standard care (Other)
standard care + Mepilex® Border
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Intervention: Mepilex® Border dressing (Combination Product)
standard care + Mepilex® Border
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Intervention: Standard care (Other)
Outcomes
Primary Outcomes
Pressure ulcer incidence
Time Frame: 0-20 days
Incidence of sacral pressure ulcers acquired during patients' hospital stay
Secondary Outcomes
No secondary outcomes reported