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Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI

NCT04165395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2019-11-18

No results posted yet for this study

Summary

This study evaluates the effect of the application of a five-layer foam dressing on the sacrum as well as a boot applied on the heels as preventive measures in the development of pressure ulcers in patients hospitalized with spinal cord injury. In order to study their effectiveness in preventing wounds, we will compare the number of wounds that developed on the sacrum and heels in participants with and without preventive treatments. The study will also assess the severity of pressure ulcers in participants with and without preventive treatment if they do develop. Half of the participants will receive the usual standard care for the prevention of pressure ulcers without dressing and boot, while the other half, in additon to standard of care, will also have a preventive dressing on the sacrum as well as Heelmedix boot applied alternately on each foot.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Five-layer foam dressing

Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery

DEVICE

Heelmedix boot

Heelmedix boot will be installed alternately from one foot to the other.

Sponsors & Collaborators

  • Medline Industries

    collaborator INDUSTRY

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Principal Investigators

  • Andréane Richard-Denis, M.D., MSC. · CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

  • Jean-Marc Mac-Thiong, M.D., Ph. D., · CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Canada

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 NCT04165395 on ClinicalTrials.gov