DermaTherapy White paper

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CLINICAL DATA TAKEN FROM PUBLISHED MEDICAL ARTICLES. COPIES ARE AVAILABLE UPON REQUEST.
WHITE PAPER
DermaTherapy® & Hospital Care: Making Textiles Part of the Therapeutic Process
BACKGROUND– CURRENT PRACTICES AND PRODUCTS
In hospital care settings,the itemspatientscome intothe most intimate contactwithare the bedlinens. Despite
the intimacy between bedding and patients, a total linen system has not been developed which addresses the
therapeutic process. Quite to the contrary, linens are often viewed as “housekeeping” items, with many
institutions’primaryobjective beingtominimize theirinitial purchase price. Unfortunately,intheircurrentform,
these products can and do harm some patients. They lower standards of care and increase overall costs for the
hospital.
The quality control process related to the use and laundering of bed linensis limited to visual inspection of their
appearance — primarilyforstains ortears. Even inthe highest-techareasof hospitals,noquality control process
exists for current bed linens to reflect the following facts:
 Textile productscan cause friction,abrasionandshearwiththe skinof patients,particularlywhenapatient
moves or is moved while lying in bed;
 Generic linens are not able to properly address moisture and thereby control the microclimate between
the patient’s skin and the bed linens;
 Loose fibers potentially contaminate open sores or skin wounds of patients, such as pressure ulcers;
 Shed fibers add contaminates to the ambient air in the hospital, potentially creating a source of hospital-
acquired infections; and
 Bioburden content grows rapidly on bed linens in use by patients, especially giventhat cotton represents
an ideal medium for bacterial growth.
BACKGROUND – INCIDENCE AND COST OF PRESSURE ULCERS
The financial implications related to both pressure ulcers and hospital-acquired infections are profound and
growing. The Agency for Healthcare Research and Quality (source: www.ahrg.gov) found the average cost of a
pressure ulcer per hospital stay to be $37,800. Also, Medicare no longer pays for certain hospital-acquired
conditions considered preventable, including pressure ulcers and certain infections. Hospital-acquired conditions
account for more than 12 percentof total legal liabilityinsurance paymentsmade onbehalf of hospitals.Annually,
more than 17,000 US lawsuitsare filedrelatedtopressure ulcers,secondonlyto wrongful deathclaims. Average
lengths of stay for hospitalizations principally involving pressure wounds are nearly three times longer than
hospitalizations with no diagnosis of pressure ulcers.
THE SOLUTION – DERMATHERAPY TEXTILE PRODUCTS
Standard Textile and Precision Fabrics Group realized the urgent need to make bed linens integral elements of
the therapeuticprocessand therebyincrease the standardofcare and save billionsofdollarsinhealthcare costs.
Our objective was to develop the next generation of healthcare linens that would reduce the development of
pressure ulcers; eliminate a source of potential airborne contamination inside hospitals; and lower overall
healthcare costs. Ourscientistsdevelopedmedicallyengineered,patented DERMATHERAPYtextileproductswhich
manage moisture, while reducing friction and shear on the patient’s skin. In recognition of DERMATHERAPY bed
linens’ performance in clinical trials, FDA granted 510(k) clearance to bed linens made with DERMATHERAPY
fabricsas a ClassI medical device intendedforuse bypatientsinhospital settingswhoare susceptible topressure
ulcers. (FDA Reg. No. K061242)

2. _____________________________________________________________________________________________
CLINICAL DATA TAKEN FROM PUBLISHED MEDICAL ARTICLES. COPIES ARE AVAILABLE UPON REQUEST.
These products are virtually lint-free, do not shed fibers or air-borne contaminants, and are much drier, cooler-
feeling, silk-like and smoother — all of which are critical factors in optimizing the microclimate between the
patient’s skin and the patient’s support surface.
A surgical-grade quaternary ammonium antimicrobial agent is applied to DERMATHERAPY fabric. Cytotoxicity,
intracutaneous reactivity, and skin sensitization tests have been conducted to evaluate the biocompatibility of
DERMATHERAPY bedlinens atvariouspointsof itsuse life. Studieshavealsobeendone toquantifyandanalyzethe
potential of the antimicrobial agent leaching from DERMATHERAPY bed linens. Test results demonstrated that
there is no safety risk to patients.
RESULTS FROM THE CLINICAL STUDIES
The performance of these DERMATHERAPY products has been independently evaluated in three of the largest
clinical studies ever conducted with respect to pressure ulcers – one in a medical renal unit, one in a surgical
intensive care unit,andanotherintelemetry,urology, andintensive care units.Theyinvolved2,009 patients at 18
yearsof age andolder(1,012 incontrol groupsusingcotton-blendlinens,and997usingDERMATHERAPYproducts).
The improvedstandard ofcare fromusing DERMATHERAPY products resultedin consistentreductions in facility-
acquired pressure ulcers in a wide range of clinical settings and patient populations.
INCIDENCE OF FACILITY-ACQUIRED PRESSURE ULCERS
Acute Care Clinical Trials Total Patients COTTON-BLEND DERMATHERAPY P
Medical Renal Unit 307 12.3% 4.6% .01
Surgical IntensiveCare Unit 275 7.5% 0.0% .01
Telemetry,Urology,&Intensive Care Units 1,427 11.5% 3.1% <.001
Overall, length-of-stay for patientsfor whom DERMATHERAPY products were usedwas reduced by 7.8%. Also of
note, patients and nurses involved in the clinical studies expressed a strong preference for DERMATHERAPY.
OTHER ATTRIBUTES OF DERMATHERAPY PRODUCTS
DERMATHERAPY products are alsoenvironmentallyfriendly. Incomparisonwithexistinghospital bedlinens,they
are 37% lighter in weight. They clean easier and are more resistant to stains. They dry more quickly and require
less energy to launder. Their service life is dramatically longer: while, on average, incumbent products provide
~50 usages(with sheddingof fibersoccurringeachtime aproductisusedorlaundered), DERMATHERAPYproducts
can be laundered atleast40% to50% longerwithoutlosingtheirpropertiesandwithvirtuallynosheddingof fibers.
DERMATHERAPY productshave the potential toreduce linensgoingto medical waste streams by more than 68%.
CONCLUSIONS
DERMATHERAPY bed linens more efficientlymanage moisture, friction and shear, which are causally related to
hospital-acquired pressure ulcers; reduce the likelihood of patients developing pressure ulcers; reduce air-borne
contaminates; raise standards of care; and improve patient comfort. DERMATHERAPY also represents very
significantsystemcostsavingsforhospitals. Bedlinensmade withDERMATHERAPYfabricsare intendedforuse by
patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers.