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.

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