Pressure UlcerNCT02363842
Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)
A study testing Skin IQ™ MCM Coverlet and Pressure redistribution surface in people with Pressure Ulcer, run by Arjohuntleigh at 4 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Skin IQ™ MCM Coverlet and Pressure redistribution surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia
Sandra Burks
David Mercer
- Recruiting
University of Texas- Southwestern
Dallas, Texas
Condy Dolezal
- Recruiting
Integris Baptist Medical Center
Oklahoma City, Oklahoma
Kristin Jones
Canada1 site, 1 recruiting
- Recruiting
Rouge Valley Health
Toronto, Ontario
Rose Raizman
About this study
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
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.
Read the 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).
- Conditions
- Pressure Ulcer
- Being tested
- Skin IQ™ MCM Coverlet, Pressure redistribution surface
- Keywords
- Pressure Ulcer, Skin IQ MCM coverlet, Pressure redistribution surfaces
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin IQ™ MCM CoverletDevice
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 surfaceOther
Standard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown
| Study group | Role | What they receive |
|---|---|---|
| Skin IQ™ MCM Coverlet | Experimental | 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 Receives: Device: Skin IQ™ MCM Coverlet |
| Pressure redistribution surface | Active comparator | Commercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown Receives: Other: Pressure redistribution surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 60 days for incidence of Pressure Ulcer development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjohuntleigh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Magellan Medical Technology Consultants, Inc.
- Responsible party
- Sponsor
- Investigators
- Alastair McLeod, Study director, Arjohuntleigh, Inc.Jean DeLeon, MD, Principal investigator, UTSWSusan Jones, PhD APRNCNS, Principal investigator, Integris Baptist HospitalRose Ralzman, RNMScCETN(c), Principal investigator, Rouge Valley Health SystemDavid Mercer, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363842
- Sponsor's protocol ID
- SIQ2014-01
- Status last verified
- Aug 2015
- First submitted
- 10 Feb 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Treatment of Pressure Ulcers: Quick Reference Guide. 2009.
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.
PubMed 18493092Lindgren 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.
PubMed 15005664Cullum 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.
PubMed 15266452Gray 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.
PubMed 17413827Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.
PubMed 18184980Reger 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.
PubMed 17978415Zhong 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.
PubMed 16702052Reger 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.
PubMed 11346834
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02363842
- Acronym / sponsor ID
- SIQ2014-01
- Conditions
- Pressure Ulcer
- Keywords
- Pressure Ulcer, Skin IQ MCM coverlet, Pressure redistribution surfaces
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- ArjohuntleighIndustry (pharma, biotech, devices)
- Collaborators
- Magellan Medical Technology Consultants, Inc.
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin IQ™ MCM Coverlet | Experimental | Device: Skin IQ™ MCM CoverletSkin 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 |
| Pressure redistribution surface | Active comparator | Other: Pressure redistribution surfaceCommercially available pressure redistribution surface already in use at participating study sites (SOC) to manage patients at risk for tissue breakdown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin IQ™ MCM CoverletTest 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. | Device | Skin IQ™ MCM Coverlet |
| Pressure redistribution surfaceStandard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown | Other | Pressure redistribution surface |
Primary outcome
Incidence of Pressure Ulcer development
Time frame: Up to 60 days for 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- BackgroundTreatment of Pressure Ulcers: Quick Reference Guide. 2009.
- Background: PubMed 18493092Girouard 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.
- Background: PubMed 15005664Lindgren 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.
- Background: PubMed 15266452Cullum 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.
- Background: PubMed 17413827Gray 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.
- Background: PubMed 18184980Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.
- Background: PubMed 17978415Reger 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.
- Background: PubMed 16702052Zhong 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.
- Background: PubMed 11346834Reger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair McLeod study director
Arjohuntleigh, Inc.
Jean DeLeon, MD principal investigator
UTSW
Susan Jones, PhD APRNCNS principal investigator
Integris Baptist Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin IQ™ MCM Coverlet and Pressure redistribution surface in people with Pressure Ulcer, run by Arjohuntleigh at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alastair McLeod (+44(0)1582745768, Alastair.McLeod@arjohuntleigh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pressure Ulcer development (time frame: Up to 60 days for incidence of Pressure Ulcer development). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363842, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.