Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI (NCT04165395) | Clinical Trial Compass
UnknownNot Applicable
Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI
Canada165 participantsStarted 2019-08-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: During the acute care hospitalization, approx 6 weeks
2
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
Timeframe: During the acute care hospitalization, approx 6 weeks
Trial details
NCT IDNCT04165395
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal