The effectiveness of antibacterial therapeutic clothing based on silver or chitosan as compared with non-antibacterial therapeutic clothing in patients with moderate to severe atopic dermatitis (ABC trial): study protocol for a pragmatic randomized controlled trial

Aviël Ragamin,Karin B Fieten,Marieke S Jansen,Renske Schappin,Suzanne G M A Pasmans,Marlies De Graaf,Madelon B Bronner,Thomas Rustemeyer,Ron A Tupker,Suzanne Polinder,Bernd W M Arents,Margreet L E Romeijn,Jill De Wit,Frank H J Schuren,Marie L A Schuttelaar,Minke M F Van Mierlo

doi:10.1186/s13063-021-05836-y

Abstract

BackgroundAtopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe. Since 2000, therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced for AD. These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. Increased colonization with S. aureus is correlated with increased AD severity. The antimicrobial effects of silver and chitosan have been demonstrated before. At this point, there is insufficient evidence for the effectiveness of antibacterial therapeutic clothing in patients with AD.MethodsThis is a pragmatic randomized controlled double-blind multi-center trial comparing the effectiveness of antibacterial therapeutic clothing based on silver or chitosan as compared with non-antibacterial therapeutic clothing in patients with moderate to severe AD. A total of 165 participants, aged 0 to 80, diagnosed with moderate to severe AD are included. The study is performed in the Erasmus MC University Medical Center, University Medical Center Groningen, University Medical Center Utrecht, Amsterdam University Medical Centers, and St. Antonius Hospital Nieuwegein. Patients will be randomized 1:1:1 into one of the three intervention groups: group A will receive therapeutic clothing without antimicrobial agents, group B will receive microbial growth reducing therapeutic clothing based on chitosan, and group C will receive antimicrobial clothing based on silver. All therapeutic clothing is to be worn at night during the 12-month intervention period. Usual care is continued. The primary objective is to assess the effectiveness of antibacterial clothing (silver and chitosan group) as compared to non-antibacterial clothing assessed with the Eczema Area and Severity Index at 12 months compared to baseline. Secondary outcomes include between-group differences in physician- and patient-reported outcome measures, topical therapy use, S. aureus skin colonization, and safety. Data will be collected at baseline and after 1 month, 3 months, 6 months, and 12 months. A cost-effectiveness analysis will be performed.DiscussionThis trial will provide data on the effectiveness, cost-effectiveness, and safety of antibacterial therapeutic clothing for patients with AD.Trial registrationClinicalTrials.gov NCT04297215. Registered on 5 March 2020

Highlights

Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe
The primary objective is to assess the effectiveness of antibacterial clothing as compared to non-antibacterial clothing assessed with the Eczema Area and Severity Index at 12 months compared to baseline
The Dutch National Health Care Institute underlined the need for a trial to establish whether or not antibacterial therapeutic clothing iseffective for AD. In this randomized controlled trial, we aim to investigate theeffectiveness of antibacterial therapeutic clothing as compared to therapeutic clothing without these agents on reducing AD severity, thereby providing high-quality evidence to inform clinical practice

Summary

Introduction

Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe. Since 2000, therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced for AD. These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. Cotton bandages were used to cover the affected skin This provides a fixation of creams and ointments, thereby possibly enhancing their action. In the year 2000, therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced. Antibacterial therapeutic clothing aims to reduce skin colonization with Staphylococcus (S.) aureus.

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