Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
1 other identifier
interventional
75
1 country
1
Brief Summary
The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedJuly 27, 2011
July 1, 2011
8 months
May 11, 2011
July 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention and reduction in the incidence of pressure ulcers
The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.
Weekly assessments for 1 year
Secondary Outcomes (1)
Reduction of bacterial contamination
Weekly for 8 weeks
Study Arms (1)
DermaTherapy® Linen group
EXPERIMENTALThe DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Interventions
DermaTherapy® Linen is a 100% synthetic silk-like fabric technology designed to provide a cleaner, drier and smoother surface between the skin and support systems for a healthy micro-climate. Subjects in the DermaTherapy® Linen Group are compared to subjects receiving usual care - bed linen made of cotton-blend fabrics.
Eligibility Criteria
You may qualify if:
- Residents admitted for long term care.
- Residents admitted for Hospice Care with an expected length of stay greater than one week.
- Residents with an expected length of stay equal to or greater than 90 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Precision Fabrics Group, Inc.lead
- US Department of Veterans Affairscollaborator
Study Sites (1)
Durham VA Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack I Twersky, MD
Durham VA Medical Center, Duke University Medical Center
- PRINCIPAL INVESTIGATOR
Kenneth E Schmader, MD
Durham VA medical Center, Duke University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2011
First Posted
July 27, 2011
Study Start
September 1, 2010
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
July 27, 2011
Record last verified: 2011-07