Clinical trial NCT04165395: Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Pressure Ulcers
Pressure Injury
Spinal Cord Injury
Prophylactic
Dressing
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
Collaborators: name: Medline Industries
First posted: 2019-11-18
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Computer generated set of random numbers to determine group allocation with a ratio of 1:1
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: During the acute care hospitalization, approx 6 weeks
measure: 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
Secondary outcomes:
measure: 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
timeFrame: During the acute care hospitalization, approx 6 weeks
measure: 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
timeFrame: During the acute care hospitalization, approx 6 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
state: Quebec
Study officials:
affiliation: CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
name: Andréane Richard-Denis, M.D., MSC.
role: PRINCIPAL_INVESTIGATOR
affiliation: CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
name: Jean-Marc Mac-Thiong, M.D., Ph. D.,
role: STUDY_DIRECTOR
References:
citation: Denis AR, Feldman D, Thompson C, Mac-Thiong JM. Prediction of functional recovery six months following traumatic spinal cord injury during acute care hospitalization. J Spinal Cord Med. 2018 May;41(3):309-317. doi: 10.1080/10790268.2017.1279818. Epub 2017 Feb 15.
citation: Thompson C, Mutch J, Parent S, Mac-Thiong JM. The changing demographics of traumatic spinal cord injury: An 11-year study of 831 patients. J Spinal Cord Med. 2015 Mar;38(2):214-23. doi: 10.1179/2045772314Y.0000000233. Epub 2014 Aug 6.
citation: Richard-Denis A, Feldman DE, Thompson C, Mac-Thiong JM. The impact of acute management on the occurrence of medical complications during the specialized spinal cord injury acute hospitalization following motor-complete cervical spinal cord injury. J Spinal Cord Med. 2018 Jul;41(4):388-396. doi: 10.1080/10790268.2017.1350331. Epub 2017 Jul 19.
citation: Richard-Denis A, Thompson C, Bourassa-Moreau E, Parent S, Mac-Thiong JM. Does the Acute Care Spinal Cord Injury Setting Predict the Occurrence of Pressure Ulcers at Arrival to Intensive Rehabilitation Centers? Am J Phys Med Rehabil. 2016 Apr;95(4):300-8. doi: 10.1097/PHM.0000000000000381.
citation: Richard-Denis A, Beausejour M, Thompson C, Nguyen BH, Mac-Thiong JM. Early Predictors of Global Functional Outcome after Traumatic Spinal Cord Injury: A Systematic Review. J Neurotrauma. 2018 Aug 1;35(15):1705-1725. doi: 10.1089/neu.2017.5403. Epub 2018 Apr 17.
citation: Padula WV, Mishra MK, Makic MB, Sullivan PW. Improving the quality of pressure ulcer care with prevention: a cost-effectiveness analysis. Med Care. 2011 Apr;49(4):385-92. doi: 10.1097/MLR.0b013e31820292b3.
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