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

University Hospital, Clermont-Ferrand478 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

478

Conditions

Pressure Ulcers Prevention Skin Ulcer

Interventions

Mepilex® Border dressingCOMBINATION_PRODUCT

Soft silicone self-adherent dressing (5-layers)

Standard careOTHER

The control group will receive pressure ulcer prevention standard care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chu Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Outcomes

Primary Outcomes

Pressure ulcer incidence

Incidence of sacral pressure ulcers acquired during patients' hospital stay

Time frame: 0-20 days

Central Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63 drci@chu-clermontferrand.fr

Data from ClinicalTrials.gov

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