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

Study Overview
=================
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).

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

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Device: Skin IQ™ MCM Coverlet
* Other: Pressure redistribution surface


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin IQ™ MCM Coverlet<br>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 | Device: Skin IQ™ MCM Coverlet<br>* Test article is the Skin IQ™ MCM, a Class II 510k exempt product. It is an overlay coverlet indicated to be used in conjunction with a pressure redistribution surface in order to aid in the prevention and treatment of skin breakdown and pressure ulcers for patients who require microclimate management of the skin.<br>|
| Active Comparator: Pressure redistribution surface<br>Commercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown | Other: Pressure redistribution surface<br>* Standard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pressure Ulcer development | Up to 60 days for incidence of Pressure Ulcer development; beyond 60 days, only hospital discharge date and disposition will be collected | Up to 60 days for incidence of Pressure Ulcer development | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure Ulcer, Skin IQ MCM coverlet, Pressure redistribution surfaces