DermaSheets Studies


 

An Open-Label Pilot Study to Evaluate the Efficacy of a Silk-Like Bedding Fabric (DermaSheets®)

 

As used in the treatment of Mild Atopic Dermatitis this study, completed February 2006, was carried out by the Wake Forest University School of Medicine ,Department of Dermatology, in Winston-Salem, North Carolina. The principal investigator was Alan B. Fleischer, Jr., MD.


STUDY DESIGN:
This study involved patients with mild atopic dermatitis (>5% Body Surface Area and 2 or 3 on the Investigator Global Assessment scale). Thirty-seven subjects (average age 16; female 78%) were enrolled. Patients were assigned to sleep on the experimental fabric, in the form of a bed sheet set that included a pillow case, a flat top sheet, and a fitted bottom sheet. The study consisted of an 8-week Treatment Phase. Subjects were permitted to apply moisturizer as needed during the day and in the evening. Subjects were not permitted to use any topical or systemic medication to treat atopic dermatitis while participating in the study.

The primary outcome was the investigator assessment of severity of atopic dermatitis, erythema 1, papulation/induration 2, excoriation 3, lichenification 4, scaling, oozing/crusting and global improvement from baseline to week 8. The severity of atopic dermatitis was measured using the Investigator Global Assessment (IGA) scale5 and the Eczema Area Severity Index6 (EASI). The secondary outcome was patient assessment of itching and their quality of life. The itching of the subject was measured by the Visual Analog Scale. Satisfaction with the bedding was measured using a Quality of Life Questionnaire at Baseline and Week 8.


In the graphs that follow, “Baseline” results depict assessments of the patients at the beginning of the study, prior to treatment phase. “Week 8” results depict assessments of patients after using the DermaSheets® bedding for 8 weeks.

STUDY RESULTS:
Improvements in Atopic Dermatitis
Using Investigator Global Assessment

 DermaSheets-BL-Chart.jpg

Data in this case had a p-value of 0.0257 using the Wilcoxon Signed Rank Test, indicating that a 97.4% chance that the improvement seen in the study was not a random result.

1 Erythema is redness of the skin caused by increased blood flow to the capillaries.
2 Papulation/induration is redness with skin breakout.
3 Excoriation is the loss of the top layer of skin caused by scratching.
4 Lichenification is thick, leathery skin, usually as a result of constant rubbing or scratching.
5 Investigator Global Assessment scale, or IGA, is used to rate the severity of atopic dermatitis.
6 Eczema Area Severity Index, or EASI, is used to rate the severity of eczema.

 DermaSheets-Severity-Index.jpg

Improvements in Quality of Life

Assessment of Normal Cotton Bedding at Baseline

 DermaSheets-Asses-Chart-1.jpg

 Assessment of DermaSheets® Bedding after 8 Weeks

DermaSheets-Asses-Chart-2.jpg

 

CONCLUSIONS:

In this study of patients with mild atopic dermatitis, statistically significant improvements were demonstrated in the severity of atopic dermatitis, eczema, the level of itching, and perceived quality of life after only eight weeks of using DermaSheets® bedding. In comparison with their current cotton bedding, study participants using DermaSheets® bedding reported significant improvements in:

• The amount of itching that they experienced
• Their tendency to scratch
• Their overall skin appearance
• The amount of uninterrupted sleep
• The amount of moisturizers they used

 

Night Sweats Trial

Twenty-five participants were made up of people - mostly women - who have night sweats, hot flushes, or were going through menopause.  They were given a complete set of DermaSheets to use continuously for 8 weeks.

Measured Improvements in Quality of Life

 CoolSheets_Asses_1.jpg

 

 CoolSheets_Asses_2.jpg

CONCLUSIONS

In this study of people who have night sweats, hot flushes, or were going through menopause, significant improvements were demonstrated after only eight weeks of using DermaSheets bedding.

In comparison with their current cotton bedding, study participants using DermaSheets bedding reported significant improvements in:

  • The amount of uninterrupted sleep that they experienced
  • Their ability to keep cool 
  • Their ability to keep dry
  • The amount of sweating
  • And the level of perceived comfort

Over 92% of total women, and women going through menopause, reported some level of improvement. All participants experiencing night sweats reported improvements, with 75% reporting significant improvements. Overall, 93% of study participants reported improvements in their quality of life

 

Pressure Ulcer Trials

References for trials using DermaSheets in the treatment of Pressure Ulcers

Prospective, Nonrandomized Controlled Trials to Compare the Effect of a Silk-Like Fabric to Standard Hospital Linens on the Rate of Hospital-acquired Pressure Ulcers. Coladonato J, Smith A, Watson N, Brown AT, McNichol LL, Clegg A, McPhail L, Griffin T, Montgomery TG.  J Ostomy Wound Management 2012; 58(10):14-31.
A Retrospective, Nonrandomized, Before-and-After Study of the Effect of Linens Constructed of Synthetic Silk-like Fabric on Pressure Ulcer Incidence. Smith A, McNichol LL, Amos MA, Mueller G, Griffin T, Davis J; McPhail L, Montgomery TG. J Ostomy Wound Management 2013;59(4):28-33.