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



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Gastrointestinal
Therapuetic Areas:Dermatology / Plastic Surgery, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:February 2016
Contact:Alastair McLeod
Email:Alastair.McLeod@arjohuntleigh.com
Phone:+44(0)1582745768

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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.

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).

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
We found this trial at
4
sites
Toronto, Ontario
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Toronto,
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Mercer
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Dallas, Texas 75390
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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