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

P

Precision Fabrics Group

Status

Unknown

Conditions

Pressure Ulcers

Treatments

Device: DermaTherapy® Linen and underpads.

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01355666
DermaTherapy

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 1 patient group

DermaTherapy® Linen group
Experimental group
Description:
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Treatment:
Device: DermaTherapy® Linen and underpads.

Trial contacts and locations

1

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Central trial contact

Kenneth E Schmader, MD; Jack I Twersky, MD

Data sourced from clinicaltrials.gov

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