Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)
Status unconfirmed · Not applicable
Conditions studied: Pressure Ulcer
In brief
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.
Key facts
- Study ID
- NCT02363842
- Run by
- Arjohuntleigh
- People needed
- 160
- Starts
- 2015-04-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2015-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
- University of Texas- Southwestern — Dallas, Texas, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- Rouge Valley Health — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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