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

Primary Purpose

Pressure Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Skin IQ™ MCM Coverlet

Pressure redistribution surface

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure Ulcer, Skin IQ MCM coverlet, Pressure redistribution surfaces

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Integris Baptist Medical CenterRecruiting
University of Texas- SouthwesternRecruiting
University of VirginiaRecruiting
Rouge Valley HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Skin IQ™ MCM Coverlet

Pressure redistribution surface

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02363842

First Posted

February 10, 2015

Last Updated

August 12, 2015

Sponsor

Arjohuntleigh

Collaborators

Magellan Medical Technology Consultants, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02363842

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arjohuntleigh

Collaborators

Magellan Medical Technology Consultants, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

Keywords

Pressure Ulcer, Skin IQ MCM coverlet, Pressure redistribution surfaces

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Skin IQ™ MCM Coverlet

Arm Type

Experimental

Arm 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

Arm Title

Pressure redistribution surface

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Skin IQ™ MCM Coverlet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Pressure redistribution surface

Intervention Description

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 Information:

Title

Incidence of Pressure Ulcer development

Description

Up to 60 days for incidence of Pressure Ulcer development; beyond 60 days, only hospital discharge date and disposition will be collected

Time Frame

Up to 60 days for incidence of Pressure Ulcer development

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alastair McLeod

Phone

+44(0)1582745768

Alastair.McLeod@arjohuntleigh.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alastair McLeod

Organizational Affiliation

Arjohuntleigh, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jean DeLeon, MD

Organizational Affiliation

UTSW

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Susan Jones, PhD APRNCNS

Organizational Affiliation

Integris Baptist Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rose Ralzman, RNMScCETN(c)

Organizational Affiliation

Rouge Valley Health System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Mercer

Organizational Affiliation

UVA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integris Baptist Medical Center

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristin Jones

Facility Name

University of Texas- Southwestern

City

Dallas

State/Province

Texas

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Condy Dolezal

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra Burks

First Name & Middle Initial & Last Name & Degree

David Mercer

Facility Name

Rouge Valley Health

City

Toronto

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rose Raizman

12. IPD Sharing Statement

Citations:

Citation

Treatment of Pressure Ulcers: Quick Reference Guide. 2009.

Results Reference

background

PubMed Identifier

18493092

Citation

Girouard K, Harrison MB, VanDenKerkof E. The symptom of pain with pressure ulcers: a review of the literature. Ostomy Wound Manage. 2008 May;54(5):30-40, 42. Erratum In: Ostomy Wound Manage. 2008 Jun;54(6):8.

Results Reference

background

PubMed Identifier

15005664

Citation

Lindgren M, Unosson M, Fredrikson M, Ek AC. Immobility--a major risk factor for development of pressure ulcers among adult hospitalized patients: a prospective study. Scand J Caring Sci. 2004 Mar;18(1):57-64. doi: 10.1046/j.0283-9318.2003.00250.x.

Results Reference

background

PubMed Identifier

15266452

Citation

Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2004;(3):CD001735. doi: 10.1002/14651858.CD001735.pub2.

Results Reference

background

PubMed Identifier

17413827

Citation

Gray M, Bohacek L, Weir D, Zdanuk J. Moisture vs pressure: making sense out of perineal wounds. J Wound Ostomy Continence Nurs. 2007 Mar-Apr;34(2):134-42. doi: 10.1097/01.WON.0000264824.95860.9e. No abstract available.

Results Reference

background

PubMed Identifier

18184980

Citation

Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.

Results Reference

background

PubMed Identifier

17978415

Citation

Reger SI, Ranganathan VK, Sahgal V. Support surface interface pressure, microenvironment, and the prevalence of pressure ulcers: an analysis of the literature. Ostomy Wound Manage. 2007 Oct;53(10):50-8.

Results Reference

background

PubMed Identifier

16702052

Citation

Zhong W, Xing MM, Pan N, Maibach HI. Textiles and human skin, microclimate, cutaneous reactions: an overview. Cutan Ocul Toxicol. 2006;25(1):23-39. doi: 10.1080/15569520500536600.

Results Reference

background

PubMed Identifier

11346834

Citation

Reger SI, Adams TC, Maklebust JA, Sahgal V. Validation test for climate control on air-loss supports. Arch Phys Med Rehabil. 2001 May;82(5):597-603. doi: 10.1053/apmr.2001.20837.

Results Reference

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

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