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

NCT ID: NCT04165395

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2021-01-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Five-layer foam dressing

Intervention Type: DEVICE

Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery

Heelmedix boot

Intervention Type: DEVICE

Heelmedix boot will be installed alternately from one foot to the other.

Interventions

Five-layer foam dressing

Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery

Intervention Type: DEVICE

Heelmedix boot

Heelmedix boot will be installed alternately from one foot to the other.

Intervention Type: DEVICE

Other Intervention Names

Opitfoam Gentle Silicone Faced Foam & Border Sacral Wound Dressing; MSC2377EP; Heelmedix; MDT823330P, MDT823330SW, MDT823330XL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medline Industries

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Andréane Richard-Denis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andréane Richard-Denis, M.D., MSC.

Role: PRINCIPAL_INVESTIGATOR

CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Jean-Marc Mac-Thiong, M.D., Ph. D.,

Role: STUDY_DIRECTOR

CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Locations

CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Geneviève Leblanc

Role: CONTACT

genevieve.leblanc.ar.cnmtl@ssss.gouv.qc.ca

1-514-338-2222 ext. 7464

Louisane Dupré

Role: CONTACT

louisane.dupre.cnmtl@ssss.gouv.qc.ca

1-514-338-2222 ext. 3696

Facility Contacts

Geneviève Leblanc

Role: primary

genevieve.leblanc.ar.cnmtl@ssss.gouv.qc.ca

1-514-338-2222 ext. 7464

Louisane Dupré

Role: backup

louisane.dupre.cnmtl@ssss.gouv.qc.ca

1-514-338-2222 ext. 3696

References

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.

Reference Type: BACKGROUND

PMID: 28198660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25096709 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28724333 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26418488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29455634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21368685 (View on PubMed)

Santamaria N, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, De Vincentis S, Ng AW, Manias E, Liu W, Knott J. A randomised controlled trial of the effectiveness of soft silicone multi-layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015 Jun;12(3):302-8. doi: 10.1111/iwj.12101. Epub 2013 May 27.

Reference Type: BACKGROUND

PMID: 23711244 (View on PubMed)

Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.

Reference Type: BACKGROUND

PMID: 21318011 (View on PubMed)

Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.

Reference Type: BACKGROUND

PMID: 27749790 (View on PubMed)

Related Links

http://www.woundsource.com/patientcondition/pressure-injuries-stage-1

Wound Source

Other Identifiers

ISS-2018-DIV31-014

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1636

Identifier Type: -

Identifier Source: org_study_id