Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)
NCT ID: NCT02363842
Last Updated: 2015-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2015-04-30
2016-02-29
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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.
Pressure redistribution surface
Commercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Magellan Medical Technology Consultants, Inc.
OTHER
Arjohuntleigh
INDUSTRY
Responsible Party
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Principal Investigators
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Alastair McLeod
Role: STUDY_DIRECTOR
Arjohuntleigh, Inc.
Jean DeLeon, MD
Role: PRINCIPAL_INVESTIGATOR
UTSW
Susan Jones, PhD APRNCNS
Role: PRINCIPAL_INVESTIGATOR
Integris Baptist Hospital
Rose Ralzman, RNMScCETN(c)
Role: PRINCIPAL_INVESTIGATOR
Rouge Valley Health System
David Mercer
Role: PRINCIPAL_INVESTIGATOR
UVA
Locations
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Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
University of Texas- Southwestern
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Rouge Valley Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Kristin Jones
Role: primary
Condy Dolezal
Role: primary
Sandra Burks
Role: primary
Rose Raizman
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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SIQ2014-01
Identifier Type: -
Identifier Source: org_study_id
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