Standard Textile and Precision Fabrics Group announce results from a clinical trial evaluating DermaTherapy® technology, published in the November 2017 issue of the American Journal of Critical Care. Authors of the study from Michigan Medicine, the academic medical center of the University of Michigan, concluded: “The use of specialty linens in addition to standard techniques for preventing pressure injuries can help prevent pressure injuries from developing in high-risk patients in intensive care units.” (American Journal of Critical Care. 2017; 26: 474-481)
The company reports that DermaTherapy® is the first and only silk-like therapeutic bedding linens to receive FDA 510(k)1 clearance as a Class I medical device that helps to reduce the likelihood of patients developing pressure injuries. Nearly 4,000 patients were included in the evaluation of DermaTherapy® on the rate of pressure injuries (PIs) in high-risk patients in the cardiovascular and surgical intensive care units at the University of Michigan hospital in Ann Arbor, Michigan.
According to the study, the 46% reduction of posterior PIs led to a potential cost savings for the health system of nearly $4 million. The article states that “cost savings more than covered the increased cost of the specialty linens. In addition, Michigan Medicine’s laundry manager, Rolando Croocks, indicated in the article that the specialty linens have withstood “repeated use and laundering for 3 times longer than cotton linens.
In the study, the researchers state: “Overall, we noted significant reductions in posterior PIs, supporting the theory that addressing microclimate can help reduce the occurrence of PIs.” DermaTherapy® therapeutic bedding addresses the patient’s microclimate by reducing shear and friction, and controlling moisture and heat.
With two U.S. patents (US 7,816,288 and US 8,283,267) and two pending patents, the DermaTherapy® system is comprised of a pillowcase, top flat sheet, bottom fitted sheet and underpad, all developed in partnership between Standard Textile Co., Inc. and Precision Fabrics Group. DermaTherapy® is a registered trademark of Precision Fabrics Group, Inc.
DermaTherapy® also has FDA clearance2 for use in the treatment of atopic dermatitis by patients who are susceptible to or may have mild atopic dermatitis, the most common form of eczema.
1 FDA 510(K) Clearance No. K152884. Indications for Use: Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy® Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin.
2 FDA 510(K) Clearance No. K061242. Indications for Use: Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy® fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.