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

NCT04165395 | Unknown

• 2 other identifiers: 2019-1636ISS-2018-DIV31-014
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Pressure Ulcers; Pressure Injury; Spinal Cord Injury; Prophylactic; Dressing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  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

  During the acute care hospitalization, approx 6 weeks

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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; Device: Heelmedix boot

Interventions

Five-layer foam dressing DEVICE

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

Also known as: Opitfoam Gentle Silicone Faced Foam & Border Sacral Wound Dressing, MSC2377EP

Intervention group

Heelmedix boot DEVICE

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

Also known as: Heelmedix, MDT823330P, MDT823330SW, MDT823330XL

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Medline Industries: collaborator

Study Sites (1)

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

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Related Publications (9)

• 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.

  PMID: 28198660 BACKGROUND

• 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.

  PMID: 25096709 BACKGROUND

• 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.

  PMID: 28724333 BACKGROUND

• 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.

  PMID: 26418488 BACKGROUND

• 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.

  PMID: 29455634 BACKGROUND

• 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.

  PMID: 21368685 BACKGROUND

• 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.

  PMID: 23711244 BACKGROUND

• 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.

  PMID: 21318011 BACKGROUND

• 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.

  PMID: 27749790 BACKGROUND

Related Links

• Wound Source

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andréane Richard-Denis, M.D., MSC.

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

  PRINCIPAL INVESTIGATOR

• Jean-Marc Mac-Thiong, M.D., Ph. D.,

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

  STUDY DIRECTOR

Central Study Contacts

Geneviève Leblanc

CONTACT

1-514-338-2222; genevieve.leblanc.ar.cnmtl@ssss.gouv.qc.ca

Louisane Dupré

CONTACT

1-514-338-2222; louisane.dupre.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Computer generated set of random numbers to determine group allocation with a ratio of 1:1

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: November 18, 2019
• Study Start: August 19, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)