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OpenTrials
Completed

NCT Number: NCT01403272

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

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.

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Key information

Conditions

Pressure Ulcers Infections Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DermaTherapy® Linen and underpads.

Device

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 names: DermaTherapy®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Precision Fabrics Group, Inc.

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2011
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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