Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)

A Randomized, Controlled Trial Assessing Use of Skin IQ™ MCM Compared to Current Standard of Care for the Management of Moisture and Temperature at the Patient/Surface Interface for Prevention of Pressure Ulcer Development

The study is a multi-center, prospective, randomized, controlled, clinical study evaluating the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially available pressure redistribution surfaces compared to standard of care (SOC). The objective of this study is to evaluate if a commercially available pressure redistribution surface when combined with the Skin IQ™ MCM coverlet will significantly reduce pressure ulcer (PU) incidence as compared to use of a commercially available pressure redistribution surface by itself by decreasing the effects of excessive moisture and temperature at the skin and surface interface.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Skin IQ™ MCM Coverlet; Other: Pressure redistribution surface

Detailed Description

This prospective, randomized, controlled study is designed to capture, evaluate and compare the effects of Skin IQ™ MCM coverlet placed over commercially available pressure redistribution surfaces versus commercially available pressure redistribution surface (SOC) used by itself to manage patients at risk for tissue breakdown.

Anticipation is that 160 Subjects will need to be screened and consented to achieve the desired sample size of 136 Subjects at up to 5 centers. Individual Subject, Standard Time of Observation: Up to 60 days for incidence of PU development; beyond 60 days, only hospital discharge date and disposition will be collected. The safety endpoint is the incidence of device-related serious adverse events (SAEs).

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alastair McLeod; Phone Number: +44(0)1582745768; Email: Alastair.McLeod@arjohuntleigh.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Rouge Valley Health
      • Contact: Rose Raizman
• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Recruiting
      • Integris Baptist Medical Center
      • Contact: Kristin Jones
  • Texas
    • Dallas, Texas, United States
      • Recruiting
      • University of Texas- Southwestern
      • Contact: Condy Dolezal
  • Virginia
    • Charlottesville, Virginia, United States
      • Recruiting
      • University of Virginia
      • Contact: Sandra Burks
      • Principal Investigator: David Mercer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject 18 years or older
• Deemed at risk for tissue breakdown by clinical staff via an institutional assessment protocol such as the Braden Scale, the Waterlow Scale or the Norton Scale.
• Subject, or their legal representative, is able and willing to sign an informed consent form (ICF) and willing to undergo all study related procedures.

Exclusion Criteria:

• Female Subjects who report being pregnant
• Subjects with any unstable spinal injury
• Subjects with chronic renal failure requiring dialysis at the time of enrollment
• Subjects with body mass index (BMI) > 39 as estimated at the time of enrollment
• Use of hyperbaric oxygen therapy (HBO) ≤30 days prior to screening
• Use of external warming and/or cooling devices
• Subjects who have been enrolled in this study previously
• Subjects, who in the investigator's opinion, would have any clinically significant condition that would impair the participants' ability to comply with the study procedures
• Diagnosed chronic skin disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Skin IQ™ MCM Coverlet; Skin IQ™ MCM coverlet used over a commercially available pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown	Device: Skin IQ™ MCM Coverlet; Test article is the Skin IQ™ MCM, a Class II 510k exempt product. It is an overlay coverlet indicated to be used in conjunction with a pressure redistribution surface in order to aid in the prevention and treatment of skin breakdown and pressure ulcers for patients who require microclimate management of the skin.
ACTIVE_COMPARATOR: Pressure redistribution surface; Commercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown	Other: Pressure redistribution surface; Standard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pressure Ulcer development	Up to 60 days for incidence of Pressure Ulcer development; beyond 60 days, only hospital discharge date and disposition will be collected	Up to 60 days for incidence of Pressure Ulcer development

Collaborators and Investigators

• Sponsor: Arjohuntleigh
• Collaborators: Magellan Medical Technology Consultants, Inc.
• Investigators: Study Director: Alastair McLeod, Arjohuntleigh, Inc.; Principal Investigator: Jean DeLeon, MD, UTSW; Principal Investigator: Susan Jones, PhD APRNCNS, Integris Baptist Hospital; Principal Investigator: Rose Ralzman, RNMScCETN(c), Rouge Valley Health System; Principal Investigator: David Mercer, UVA

Publications and helpful links

General Publications

• Zhong W, Xing MM, Pan N, Maibach HI. Textiles and human skin, microclimate, cutaneous reactions: an overview. Cutan Ocul Toxicol. 2006;25(1):23-39. doi: 10.1080/15569520500536600.
• Treatment of Pressure Ulcers: Quick Reference Guide. 2009.
• Girouard K, Harrison MB, VanDenKerkof E. The symptom of pain with pressure ulcers: a review of the literature. Ostomy Wound Manage. 2008 May;54(5):30-40, 42. Erratum In: Ostomy Wound Manage. 2008 Jun;54(6):8.
• Lindgren M, Unosson M, Fredrikson M, Ek AC. Immobility--a major risk factor for development of pressure ulcers among adult hospitalized patients: a prospective study. Scand J Caring Sci. 2004 Mar;18(1):57-64. doi: 10.1046/j.0283-9318.2003.00250.x.
• Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2004;(3):CD001735. doi: 10.1002/14651858.CD001735.pub2.
• Gray M, Bohacek L, Weir D, Zdanuk J. Moisture vs pressure: making sense out of perineal wounds. J Wound Ostomy Continence Nurs. 2007 Mar-Apr;34(2):134-42. doi: 10.1097/01.WON.0000264824.95860.9e. No abstract available.
• Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.
• Reger SI, Ranganathan VK, Sahgal V. Support surface interface pressure, microenvironment, and the prevalence of pressure ulcers: an analysis of the literature. Ostomy Wound Manage. 2007 Oct;53(10):50-8.
• Reger SI, Adams TC, Maklebust JA, Sahgal V. Validation test for climate control on air-loss supports. Arch Phys Med Rehabil. 2001 May;82(5):597-603. doi: 10.1053/apmr.2001.20837.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): February 1, 2016
• Study Completion (ANTICIPATED): February 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (ESTIMATE): February 16, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Pressure Ulcer; Skin IQ MCM coverlet; Pressure redistribution surfaces
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: SIQ2014-01