Pressure Ulcers, Prevention, Skin Ulcer, Ulcer
Conditions
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.
Interventions
COMBINATION_PRODUCTMepilex® Border dressing
Soft silicone self-adherent dressing (5-layers)
OTHERStandard care
The control group will receive pressure ulcer prevention standard care
Sponsors
Molnlycke Health Care AB
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure ulcer incidence | 0-20 days | Incidence of sacral pressure ulcers acquired during patients' hospital stay |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed