ABSTRACT
BACKGROUND: Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation; however, its role in the management of AD remains poorly understood. OBJECTIVES: To investigate the effectiveness of antibacterial therapeutic clothing + standard topical treatment in patients with moderate-to-severe AD vs. standard therapeutic clothing + standard topical treatment; and, if effectiveness was demonstrated, to demonstrate its cost-effectiveness. METHODS: A pragmatic double-blinded multicentre randomized controlled trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1 : 1 : 1 to receive standard therapeutic clothing or antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes (PROs), topical corticosteroid (TCS) use, SA colonization, safety and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed-model analyses. RESULTS: Between 16 March 2020 and 20 December 2021, 171 patients were enrolled. In total, 159 patients were included (54 in the standard therapeutic clothing group, 50 in the chitosan group and 55 in the silver group). Adherence was high [median 7 nights a week wear (interquartile range 3-7)]. Median EASI scores at baseline and at 4, 12, 26 and 52 weeks were 11.8, 4.3, 4.6, 4.2 and 3.6, respectively, in the standard therapeutic clothing group vs. 11.3, 5.0, 3.0, 3.0 and 4.4, respectively, in the chitosan group, and 11.6, 5.0, 5.4, 4.6 and 5.8, respectively, in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing group, the chitosan group [-0.1, 95% confidence interval (CI) -0.3 to 0.2; P = 0.53] or the silver group (-0.1, 95% CI -0.3 to 0.2; P = 0.58) were found. However, a small significant group × time interaction effect between the standard and silver groups was found (P = 0.03), in which the silver group performed worse after 26 weeks. No differences between groups were found in PROs, TCS use, SA skin colonization and healthcare utilization. No severe adverse events or silver absorption were observed. CONCLUSIONS: The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD.
Subject(s)
Chitosan , Dermatitis, Atopic , Dermatologic Agents , Staphylococcal Infections , Humans , Adrenal Cortex Hormones/therapeutic use , Anti-Bacterial Agents/adverse effects , Chitosan/therapeutic use , Clothing , Dermatitis, Atopic/drug therapy , Dermatologic Agents/therapeutic use , Double-Blind Method , Glucocorticoids/therapeutic use , Severity of Illness Index , Silver/therapeutic use , Treatment OutcomeABSTRACT
BACKGROUND: Hand eczema (HE) has a significant impact on patients' quality of life and work-related activities. However, little is known about the patients' perspectives on quality of care for HE. OBJECTIVES: To evaluate the patient perspective of the HE care process in a tertiary referral center. METHODS: Qualitative, semi-structured focus groups were carried out, recorded, transcribed, and analysed using an inductive-deductive thematic approach. RESULTS: Fifteen patients participated in four focus groups. Time and attention, together with being listened to and understood by the health care professional, were the most important aspects of care for HE mentioned by participants. Other aspects of care that were regarded as important were that diagnoses, causes and follow-up of HE were not always clear to the participant; more psychosocial support was needed, and that participants experienced frequent changes in doctors. Information provided by nurses was valuable, but more individualized advice was needed. CONCLUSIONS: To better meet the needs of patients, more explanation should be given about the causes of HE and the final diagnosis. Besides focusing on the treatment, it is also important to focus on its impact on the patient and options for psychosocial and peer support should be discussed. Furthermore, the beneficial role of the specialized nurse as part of integrated care was emphasized.