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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Precision Fabrics Group, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Precision Fabrics Group, Inc.
ClinicalTrials.gov Identifier:
NCT01355666
First received: May 13, 2011
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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 Intervention
Pressure Ulcers
Device: DermaTherapy® Linen and underpads.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Precision Fabrics Group, Inc.:

Primary Outcome Measures:
  • Prevention and reduction in the incidence of pressure ulcers [ Time Frame: Weekly assessments for 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weekly for 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
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

No publications provided

Responsible Party: Dr. Terry Montgomery, Precision Fabrics Group, inc.
ClinicalTrials.gov Identifier: NCT01355666     History of Changes
Other Study ID Numbers: DermaTherapy
Study First Received: May 13, 2011
Last Updated: May 17, 2011
Health Authority: United States: Federal Government

Keywords provided by Precision Fabrics Group, Inc.:
long term care
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
nursing home
decubitus ulcer
bed ridden
anti-microbial

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014