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

January 29, 2019 updated by: University Hospital, Clermont-Ferrand

A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

478

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Franck HENTZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard care
pressure ulcer prevention standard care
Other: Standard care
The control group will receive pressure ulcer prevention standard care
Experimental: standard care + Mepilex® Border
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Other: Standard care
The control group will receive pressure ulcer prevention standard care
Combination product: Mepilex® Border dressing
Soft silicone self-adherent dressing (5-layers)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure ulcer incidence
Time Frame: 0-20 days
Incidence of sacral pressure ulcers acquired during patients' hospital stay
0-20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Molnlycke Health Care AB

Investigators

  • Principal Investigator: Franck HENTZ, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Anticipated)

August 31, 2019

Study Completion (Anticipated)

January 31, 2020

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-418
  • 2018-A00694-51 (Other Identifier: 2018-A00694-51)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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