Clinical trial NCT02363842: Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
Skin IQ MCM coverlet
Pressure redistribution surfaces
Lead sponsor: Arjohuntleigh
Sponsor class: INDUSTRY
Collaborators: name: Magellan Medical Technology Consultants, Inc.
First posted: 2015-02-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Pressure Ulcer development
timeFrame: Up to 60 days for incidence of Pressure Ulcer development
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Dallas
country: United States
facility: University of Texas- Southwestern
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: Rouge Valley Health
state: Ontario
Study officials:
affiliation: Arjohuntleigh, Inc.
name: Alastair McLeod
role: STUDY_DIRECTOR
affiliation: UTSW
name: Jean DeLeon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Integris Baptist Hospital
name: Susan Jones, PhD APRNCNS
role: PRINCIPAL_INVESTIGATOR
affiliation: Rouge Valley Health System
name: Rose Ralzman, RNMScCETN(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: UVA
name: David Mercer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treatment of Pressure Ulcers: Quick Reference Guide. 2009.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.
citation: 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.
citation: 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.
citation: 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.