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

Primary Purpose

Pressure Ulcers, Prevention, Skin Ulcer

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Mepilex® Border dressing
Standard care
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chu Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard care

standard care + Mepilex® Border

Arm Description

pressure ulcer prevention standard care

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

Outcomes

Primary Outcome Measures

Pressure ulcer incidence
Incidence of sacral pressure ulcers acquired during patients' hospital stay

Secondary Outcome Measures

Full Information

First Posted
January 11, 2019
Last Updated
January 29, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT03823963
Brief Title
Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
Acronym
MEPICARD
Official Title
A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Molnlycke Health Care AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers, Prevention, Skin Ulcer, Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
478 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Other
Arm Description
pressure ulcer prevention standard care
Arm Title
standard care + Mepilex® Border
Arm Type
Experimental
Arm Description
pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
Intervention Type
Combination Product
Intervention Name(s)
Mepilex® Border dressing
Intervention Description
Soft silicone self-adherent dressing (5-layers)
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
The control group will receive pressure ulcer prevention standard care
Primary Outcome Measure Information:
Title
Pressure ulcer incidence
Description
Incidence of sacral pressure ulcers acquired during patients' hospital stay
Time Frame
0-20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck HENTZ
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Franck HENTZ

12. IPD Sharing Statement

Learn more about this trial

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

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