Clinical Experiences with an Antimicrobial Bed Equipment Using Zinc-Smartcel Fibers for Pronounced Atopic Dermatitis
In this clinical study we evaluated an especially designed bed equipment for in-patients with severe atopic dermatitis. Ten adult patients aged between 18 to 74 years have been investigated for 10 to 12 days. We assessed severity of atopic dermatitis, severity of pruritus, and disturbance of sleep quality during the night. The median Three-Item-Score for atopic dermatitis was 11.5 1.6 before and improved to 3 1.3. Using the 5D Itch Score, pruritus decreased from 7 1 to 3 1.1. According to the Modified Sleep-Habits Questionnaire the median value improved from 3.7 2.7 to 1.5 2 suggesting a pronounced improvement of sleep quality. Adverse events or intolerabilities have not been observed. Our data argue for a positive effect of an especially designed bed equipment on severity of atopic dermatitis and pruritus and beneficial effects on the quality of night sleep. This supports the healing process.
Uwe Wollina, Nadine Schmidt, Diana Mühle, Gesina Hansel
Neurodermatitis is a chronic inflammatory dermatosis from the group of atopic diseases. Essential pathophysiological aspects are the disturbance of the skin barrier function, the changes of the cell-mediated immunity, the IgE hyperreactivity and environmental influences. The interaction of genetic factors and environmental influences determine the severity of the individual course of the disease .
The main symptom of neurodermatitis is itching, which can be tormenting, leads to scratching effects on the skin with destruction of the skin’s protective barrier, secondary skin infections and impairment of the quality of life, especially through sleep disorders and reduction of recovery during sleep .
The disease is clinically characterized by redness (erythema), skin thickening with coarsening of the skin surface pattern (lichenification), formation of nodules, scaling and skin dryness .
Neurodermatitis is more common in the western industrial countries. It is assumed worldwide that 20% of children and approx. 3% of adults suffer from neurodermatitis .
Neurodermatitis is treated topically (with ointments, creams, etc.) and systemically. Factors to be considered outside medical treatment include clothing and bedding . They influence sensory function and thermoregulation of the skin and can support medical treatment if selected appropriately .
Disturbances of night sleep are of particular relevance to those affected. They lead to a lack of recovery during the night and have a negative influence on well-being and performance during the day. Hormonal influences, itching and scratching play a role here .
Nightwear and bedding are relevant factors for the microclimate during the night [8, 9, 10]. This prompted us to investigate the following clinical trials of FrankenstolzÓbedding in clinical everyday life.
A special bedding with Smartcel™ sensitive for pillows and blankets was used. These are fibres that have been loaded with zinc and have antimicrobial properties. Validated test methods were used to define the patient population and to determine important clinical criteria.
The diagnosis of neurodermatitis was based on the clinical criteria of Hanifin and Rajka (1980).
The severity of the disease was assessed before and after use of the bedding using a three-item severity score .
We assessed the severity of itching before and after using the bedding with the 5D Itch Scale .
The subjective sleep quality was registered using a modified Sleep-habits Questionnaire before and after application of the bedding .
Patients and setting
We carried out the examinations at the Clinic for Dermatology and Allergology at the Dresden Municipal Hospital between January and March 2018 after presentation of the project at the study centre of the Dresden Municipal Hospital and positive evaluation by them.
Consecutive patients with a definite diagnosis of neurodermatitis were included if there was an indication for inpatient treatment. All patients suffered from neurodermatitis for many years and had experience with various treatment procedures.
The minimum age was 18 years. Patients had to be legally competent and agree in writing to voluntarily participate in the trial. The bedding was used during the period of inpatient treatment, between 10 and 12 days. The bedding was provided adjuvantly to the dermatological treatment.
A total of 10 patients were included. There were 3 men and 7 women. The age was between 18 and 74 years (median 59 years, standard deviation 18.7 years).
Three-item severity score (Wolkerstorfer 1999)
Before using the bedding, the score was between 9 and 15 (maximum value 15), after which it dropped to values between 1 and 5. The median score at the beginning was 11.5 ±1.6 and improved to 3 ±1.3.
5D Itch Scale (Elman et al. 2010)
The duration of the itching attacks was estimated between 1 (< 6 hours/day) and 4 (24 hours/day) prior to the observational study. The severity of itching was between 3 and 4 (“severe” to “unbearable”). At the end of the observational study, the duration of itching was 1-2 (> 6 hours / day up to 6-12 hours / day). The severity of the itching was given as 0-2 (“no itching” to “moderate itching”). This reduced the score from the initial value of 7 ±1 to 3 ±1.1. Modified Sleep-habits Questionnaire (Unruh et al. 2008).
Before using the bed equipment, 6 patients reported short sleep episodes. Five patients reported no restful night sleep. Of three patients, 1-3 naps per week were reported. Eight patients reported problems falling asleep and 7 reported problems sleeping through. Five patients reported waking up too early in the morning. Sleep duration on weekdays was reported to be 4-10 hours. On weekends it was also between 4-10 hours. At the end of the evaluation 3 patients still had short sleep episodes (-50%). Nine out of 10 patients reported restful night sleep. Three patients reported naps at a frequency of 1-3 / week. 3 patients still had problems falling asleep, 5 patients had problems sleeping through. 3 patients reported an early morning awakening. The sleep duration had increased by 1-2 hours in 5 patients. The sum score of the modified Sleep-habits Questionnaire decreased from 3.7 ±2.7 to 1.5 ±2.
Side effects and incompatibilities
No side effects and incompatibilities due to the bedding were observed during this post-marketing surveillance.
Tab. 1: Improvement of essential clinical parameters of neurodermatitis using a special bedding with Smartcel™ sensitive fibers with cationic zinc.
Itching and sleep quality disorders are major problems in patients with neurodermatitis that can negatively affect quality of life in general, but also performance and ability to work. In addition to medical treatment, the use of suitable textiles improves sleep and sleep quality and reduces itching overnight [8, 9, 10, 14]. In addition, textile materials enable a favourable influence on the skin microbiome, which is disturbed in neurodermatitis [15 – 18]. In the present observational study with a FrankenstolzÓbedding based on Smartcel™ sensitive, various clinical parameters were recorded in neurodermatitis patients, in particular itching and sleep quality. It must be taken into account that the selection of patients concerned the particularly severe manifestations of neurodermatitis in adults. These patients showed severe itching attacks of longer daily duration. The quality of sleep was clearly negative. Based on clinical experience, medical treatment reduces the inflammation, but itching and sleep disorders do not occur in parallel, but respond with a delay.
Smartcel™ sensitive has antimicrobial properties due to the binding of Zn- cations . We were able to show that a beneficial effect on itching and sleep quality can be achieved within 10-12 days of adjuvant use of the special bedding for medical treatment (Table 1). It must be taken into account that the inpatient stay does not provide a habitual sleeping environment, which is likely to have an aggravating effect. Also, with regard to the age structure (50% of the patients were older than 60 years) sleep problems are to be found more frequently.
Nevertheless, the results show that both sleep-in and sleep-through disorders were reduced. In the modified Sleep-habits Questionnaire, the median value decreased from 3.7±2.7 to 1.5 ±2, corresponding to a significant improvement in sleep quality and improved recovery during night sleep.
But, also the itching and the signs of inflammation of neurodermatitis improved. The median Three-Item score at the beginning was 11.5 ±1.6 and improved to 3 ±1.3. This is a very clear result, due to medical therapy, but also due to the adjuvant bedding. The itching was also reduced in the 5D Itch score from 7 ±1 to 3 ±1.1. Side effects or intolerances did not occur.
In this observational study, we were able to determine a positive effect of a special bedding with Zn- cations on the severity of neurodermatitis, the associated painful itching and, last but not least, the quality of sleep. This supports the healing process.