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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Five-layer foam dressing
* Device: Heelmedix boot


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Computer generated set of random numbers to determine group allocation with a ratio of 1:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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<br>* Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery<br>* Other names: MSC2377EP;Device: Heelmedix boot<br>* Heelmedix boot will be installed alternately from one foot to the other.<br>* Other names: MDT823330P, MDT823330SW, MDT823330XL;|

What is the study measuring?
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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 | 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 | 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 | 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 | Grade of PU based on the NPUAP grading system | During the acute care hospitalization, approx 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure Ulcers, Pressure Injury, Spinal Cord Injury, Prophylactic, Dressing