NCT03823963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
478

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

January 11, 2019

Last Update Submit

January 29, 2019

Conditions

Pressure UlcersPreventionSkin UlcerUlcer

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcer incidence

    Incidence of sacral pressure ulcers acquired during patients' hospital stay

    0-20 days

Study Arms (2)

Standard care

OTHER

pressure ulcer prevention standard care

Other: Standard care

standard care + Mepilex® Border

EXPERIMENTAL

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

Combination Product: Mepilex® Border dressingOther: Standard care

Interventions

Mepilex® Border dressingCOMBINATION_PRODUCT

Soft silicone self-adherent dressing (5-layers)

standard care + Mepilex® Border
Standard careOTHER

The control group will receive pressure ulcer prevention standard care

Standard carestandard care + Mepilex® Border

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Pressure UlcerSkin UlcerUlcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Franck HENTZ

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 31, 2019

Study Start

December 10, 2018

Primary Completion

August 31, 2019

Study Completion

January 31, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

FR(1)