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

NCT03823963 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2019-01-31

No results posted yet for this study

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.

Conditions

  • Pressure Ulcers
  • Prevention
  • Skin Ulcer
  • Ulcer

Interventions

COMBINATION_PRODUCT

Mepilex® Border dressing

Soft silicone self-adherent dressing (5-layers)

OTHER

Standard care

The control group will receive pressure ulcer prevention standard care

Sponsors & Collaborators

  • Molnlycke Health Care AB

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Franck HENTZ · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-08-31
Completion
2020-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823963 on ClinicalTrials.gov