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

November 13, 2019 updated by: Andréane Richard-Denis, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

A Randomized Controlled Trial of the Effectiveness of a Five-layer Foam Dressing and the Heelmedix Boot for the Acute Prevention of Sacral and Heel Pressure Ulcers After Spinal Cord Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Among all patient populations, individuals with spinaI cord injury are most vulnerable to pressure ulcers due to prolonged and severe immobilization, moisture exposure related to sphincters incontinence, friction and shear forces associated with difficult transfers, as well as abnormal micro vascular blood flow secondary to a disrupted autonomic function below the level of injury. These factors contribute to ischemia of the skin and underlying tissues over bony prominences, which lead to increased risk of pressure ulcers. Most severe spinal cord injuries are associated with higher risk of developing pressure ulcers and presenting more severe pressure ulcers. The sacral area and heels are most at risk for pressure ulcers in the spinal cord injury population. Consequently, prevention of pressure ulcers during the acute care hospitalization is of utmost importance. Patients will be randomized to the intervention group (prophylactic placement of foam dressing over sacrum and placement of a Heelmedix boot) or the control group (no prophylactic foam dressing over sacrum and no Heelmedix boot). Both groups will receive the standard-of-care at the facility for the prevention of pressure ulcers. The standard care can include a regular evaluation of the skin, a nutritional evaluation, the management of incontinence, the use of a gel mattress, the use of a low air loss pressure-reliving mattress, the use of safe patient mobilization, weekly assessment by a physiatrist, a change of position every 2 hours, as well as occupational therapy and physical therapy.

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Five-layer foam dressing
Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery
Other Names:
  • Opitfoam Gentle Silicone Faced Foam & Border Sacral Wound Dressing
  • MSC2377EP
Device: Heelmedix boot
Heelmedix boot will be installed alternately from one foot to the other.
Other Names:
  • Heelmedix
  • MDT823330P, MDT823330SW, MDT823330XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Incidence of new PU at the sacrum during the acute care hospitilization
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
Incidence of new PU at the heel area during the acute care hospitilization
During the acute care hospitalization, approx 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the severity of PU 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 controls
Time Frame: During the acute care hospitalization, approx 6 weeks
Grade of PU based on the NPUAP grading system
During the acute care hospitalization, approx 6 weeks
Compare the severity 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
Grade of PU based on the NPUAP grading system
During the acute care hospitalization, approx 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Medline Industries

Investigators

  • Principal Investigator: Andréane Richard-Denis, M.D., MSC., CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
  • Study Director: Jean-Marc Mac-Thiong, M.D., Ph. D.,, CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1636
  • ISS-2018-DIV31-014 (Other Identifier: Medline Industries, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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