Recruiting

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

Sponsor:

Arjohuntleigh

Code:

NCT02363842

Conditions

Pressure Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Skin IQ™ MCM Coverlet

Pressure redistribution surface

Study Details

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.

Conditions

Pressure Ulcer

Study ID

NCT02363842

Start date

Apr, 2015

Status verified date

Aug, 2015

Completion date

Feb, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Skin IQ™ MCM Coverlet

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

active comparator: Pressure redistribution surface

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

Interventions

Skin IQ™ MCM Coverlet

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.

Pressure redistribution surface

Standard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown

Primary outcome measure

Incidence of Pressure Ulcer development [ Time Frame: Up to 60 days for incidence of Pressure Ulcer development ]

Central Contacts and Locations

Central contacts

Alastair McLeod

+44(0)1582745768 Alastair.McLeod@arjohuntleigh.com

Locations

Integris Baptist Medical Center

Recruiting

Oklahoma City, Oklahoma, United States

University of Texas- Southwestern

Recruiting

Dallas, Texas, United States

University of Virginia

Recruiting

Charlottesville, Virginia, United States

Principal Investigator:

David Mercer

Rouge Valley Health

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Arjohuntleigh

Last update posted

Aug 14, 2015

Last verified

Aug, 2015

Keywords

Pressure Ulcer
Skin IQ MCM coverlet
Pressure redistribution surfaces

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arjohuntleigh on 2015-08-14.