Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 12:54 PM
Study NCT ID:
NCT04165395
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISS-2018-DIV31-014 | OTHER | Medline Industries, Inc. | View |