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

NCT ID: NCT03823963

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Pressure Ulcers Prevention Skin Ulcer Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care

pressure ulcer prevention standard care

Group Type OTHER

Standard care

Intervention Type OTHER

The control group will receive pressure ulcer prevention standard care

standard care + Mepilex® Border

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

Group Type EXPERIMENTAL

Mepilex® Border dressing

Intervention Type COMBINATION_PRODUCT

Soft silicone self-adherent dressing (5-layers)

Standard care

Intervention Type OTHER

The control group will receive pressure ulcer prevention standard care

Interventions

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Mepilex® Border dressing

Soft silicone self-adherent dressing (5-layers)

Intervention Type COMBINATION_PRODUCT

Standard care

The control group will receive pressure ulcer prevention standard care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck HENTZ

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

Phone: 04 73 75 49 63

Email: [email protected]

Facility Contacts

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Lise LACLAUTRE

Role: primary

Other Identifiers

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2018-A00694-51

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-418

Identifier Type: -

Identifier Source: org_study_id