Status:
UNKNOWN
Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Molnlycke Health Care AB
Conditions:
Pressure Ulcers
Prevention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ei...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2020
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT03823963
Start Date
December 10 2018
End Date
January 31 2020
Last Update
January 31 2019
Active Locations (1)
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1
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003