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

Arjo

Status: Unknown

Conditions: Pressure Ulcer

Treatments: Device: Skin IQ™ MCM Coverlet; Other: Pressure redistribution surface

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02363842

SIQ2014-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Skin IQ™ MCM Coverlet

Experimental group

Description:

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

Treatment:

Device: Skin IQ™ MCM Coverlet

Pressure redistribution surface

Active Comparator group

Description:

Commercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown

Treatment:

Other: Pressure redistribution surface