Recruiting

Observational Study

Sponsor:

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

Code:

NCT04165395

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Five-layer foam dressing

Heelmedix boot

Study Details

Brief 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

Study ID

NCT04165395

Start date

Aug 19, 2019

Status verified date

Sep, 2019

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male of female age 18 years of older;
  • Admitted to Hôpital du Sacré-Coeur de Montréal for a traumatic or non-traumatic spinal cord injury;
  • Spinal cord injury is either: Motor-complete (AIS A-B) or motor-incomplete (AIS C);
  • Neurological level of injury is between C0 and L2;
  • Patient or interpreter is able to understand English or French and provide informed consent.

Exclusion Criteria:

  • AIS D Incomplete spinal cord injury;
  • Cauda equina syndrome or neurological level of injury below L2;
  • Sacral or heel pressure ulcer present at admission;
  • Presence of dermatological disease or systemic disease that might interfere with the outcome assessment (active dermatitis, urticarial, etc.);
  • Skin allergy to any components or ingredients of the foam dressing;
  • Any medical condition that would endanger a patient treated with the foam dressing;
  • Patient who are pregnant or nursing.

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control group

The control group will receive the standard of care adopted at Hôpital du Sacré-Coeur de Montréal in terms of pressure ulcers prevention in the SCI population.

experimental: Intervention group

In addition to undergoing the identical standard-of-care as the control group, all patients in this group will receive a prophylactic five-layer foam dressing placed directly on the sacral area and a Heelmedix boot installed alternately on both legs

Interventions

Five-layer foam dressing

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

Heelmedix boot

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

Primary outcome measure

  • Compare the incidence of pressure ulcers at the sacrum during the acute care hospitalization after a SCI between patients treated with prophylactic five-layer foam dressing at the sacrum area and vs. controls [ Time Frame: During the acute care hospitalization, approx 6 weeks ]
  • Compare the incidence of PU at the heel during the acute care hospitalization after a SCI between patients with placement of a prophylactic Heelmedix boot and controls [ Time Frame: During the acute care hospitalization, approx 6 weeks ]

Central Contacts and Locations

Central contacts

Geneviève Leblanc

1-514-338-2222genevieve.leblanc.ar.cnmtl@ssss.gouv.qc.ca

Louisane Dupré

1-514-338-2222louisane.dupre.cnmtl@ssss.gouv.qc.ca

Locations

CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Recruiting

Montréal, Quebec, Canada, H4J 1C5

Contacts

Geneviève Leblanc

1-514-338-2222genevieve.leblanc.ar.cnmtl@ssss.gouv.qc.ca

Louisane Dupré

1-514-338-2222louisane.dupre.cnmtl@ssss.gouv.qc.ca

More Information

Sponsor

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

Last update posted

Nov 18, 2019

Last verified

Sep, 2019

Keywords

  • Pressure Ulcers
  • Pressure Injury
  • Spinal Cord Injury
  • Prophylactic
  • Dressing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2019-11-18.