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Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

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ClinicalTrials.gov Identifier: NCT01355666
Recruitment Status : Unknown
Verified May 2011 by Precision Fabrics Group, Inc..
Recruitment status was:  Recruiting
First Posted : May 18, 2011
Last Update Posted : May 18, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pressure Ulcers Device: DermaTherapy® Linen and underpads.

Detailed Description:

Additional objectives of this research study are:

  • To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study.
  • To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections.

Study nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Study Start Date : September 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DermaTherapy® Linen group
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Device: DermaTherapy® Linen and underpads.

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.

Other Name: DermaTherapy®


Outcome Measures

Primary Outcome Measures :
  1. Prevention and reduction in the incidence of pressure ulcers [ Time Frame: Weekly assessments for 1 year ]
    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.


Secondary Outcome Measures :
  1. Reduction of bacterial contamination [ Time Frame: Weekly for 8 weeks ]
    To evaluate the effectiveness of DermaTherapy® bedding to reduce the potential for bacterial contamination associated with patients' bed linens and thereby help reduce the incidence of facility-acquired infections.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355666


Contacts
Contact: Jack I Twersky, MD 919-286-0411 ext 7750 jack.twersky@ya.gov
Contact: Kenneth E Schmader, MD 919-286-0411 ext 6769 kenneth.schmader@va.gov

Locations
United States, North Carolina
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Jack I Twersky, MD    919-286-0411 ext 7750    jack.twersky@va.gov   
Contact: Kenneth E Schmader, MD    919-286-0411 ext 6769    kenneth.schmader@va.gov   
Principal Investigator: Jack I Twersky, MD         
Sponsors and Collaborators
Precision Fabrics Group, Inc.
VA Office of Research and Development
Investigators
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
More Information

Responsible Party: Dr. Terry Montgomery, Precision Fabrics Group, inc.
ClinicalTrials.gov Identifier: NCT01355666     History of Changes
Other Study ID Numbers: DermaTherapy
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Keywords provided by Precision Fabrics Group, Inc.:
pressure ulcers
stage 1
stage 2
stage 3
stage 4
wounds
sores
infection
bioburden
bacterial contamination
bed linen
sheets
underpad
skin assessment
microclimate
shear
friction
moisture
fabrics
long term care
nursing home
decubitus ulcer
bed ridden
anti-microbial

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases