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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363842
• Other study ID #: SIQ2014-01
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: August 12, 2015
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: Arjohuntleigh
• Contact: Alastair McLeod
• Phone: +44(0)1582745768
• Email: Alastair.McLeod[@]arjohuntleigh.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Canada	Rouge Valley Health	Toronto	Ontario
United States	University of Virginia	Charlottesville	Virginia
United States	University of Texas- Southwestern	Dallas	Texas
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Arjohuntleigh	Magellan Medical Technology Consultants, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (9)

Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2004;(3):CD001735. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD001735. — View 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. Review. Erratum in: Ostomy Wound Manage. 2008 Jun;54(6):8. — View 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. Review. — View Citation

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

Treatment of Pressure Ulcers: Quick Reference Guide. 2009.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Arjohuntleigh, Inc. information on Skin IQ MCM coverlet product