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

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 4

Conditions: Prevention; Ulcer; Skin Ulcer; Pressure Ulcers

Treatments: Combination Product: Mepilex® Border dressing; Other: Standard care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03823963

2018-A00694-51 (Other Identifier)

CHU-418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 478 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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478 participants in 2 patient groups

Standard care

Other group

Description:

pressure ulcer prevention standard care

Treatment:

Other: Standard care

standard care + Mepilex® Border

Experimental group

Description:

pressure ulcer prevention standard care + Mepilex® Border applied on sacrum

Treatment:

Other: Standard care

Combination Product: Mepilex® Border dressing