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

NCT02363842 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-08-14

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

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

Sponsors & Collaborators

  • Magellan Medical Technology Consultants, Inc.

    collaborator OTHER

  • Arjohuntleigh

    lead INDUSTRY

Principal Investigators

  • Alastair McLeod · Arjohuntleigh, Inc.

  • Jean DeLeon, MD · UTSW

  • Susan Jones, PhD APRNCNS · Integris Baptist Hospital

  • Rose Ralzman, RNMScCETN(c) · Rouge Valley Health System

  • David Mercer · UVA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02363842 on ClinicalTrials.gov