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

Primary Purpose

Pressure Ulcers

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DermaTherapy® Linen and underpads.
Sponsored by
Precision Fabrics Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcers focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Durham VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DermaTherapy® Linen group

Arm Description

The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduction of bacterial contamination
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.

Full Information

First Posted
May 13, 2011
Last Updated
May 17, 2011
Sponsor
Precision Fabrics Group, Inc.
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01355666
Brief Title
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Official Title
Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Precision Fabrics Group, Inc.
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DermaTherapy® Linen group
Arm Type
Experimental
Arm Description
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Intervention Type
Device
Intervention Name(s)
DermaTherapy® Linen and underpads.
Other Intervention Name(s)
DermaTherapy®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevention and reduction in the incidence of pressure ulcers
Description
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.
Time Frame
Weekly assessments for 1 year
Secondary Outcome Measure Information:
Title
Reduction of bacterial contamination
Description
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.
Time Frame
Weekly for 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jack I Twersky, MD
Phone
919-286-0411
Ext
7750
Email
jack.twersky@ya.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth E Schmader, MD
Phone
919-286-0411
Ext
6769
Email
kenneth.schmader@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack I Twersky, MD
Organizational Affiliation
Durham VA Medical Center, Duke University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth E Schmader, MD
Organizational Affiliation
Durham VA medical Center, Duke University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack I Twersky, MD
Phone
919-286-0411
Ext
7750
Email
jack.twersky@va.gov
First Name & Middle Initial & Last Name & Degree
Kenneth E Schmader, MD
Phone
919-286-0411
Ext
6769
Email
kenneth.schmader@va.gov
First Name & Middle Initial & Last Name & Degree
Jack I Twersky, MD

12. IPD Sharing Statement

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

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