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, Ron A. Tupker, Jill de Wit, Minke M.F. van Mierlo, Marieke S. Jansen, Madelon B. Bronner, Renske Schappin, Frank H.J. Schuren, Margreet L.E. Romeijn, Bernd W.M. Arents, Suzanne Polinder, Marlies de Graaf, Thomas Rustemeyer, Marie L.A. Schuttelaar, Suzanne G.M.A. Pasmans*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: 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. 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. Methods: This 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. Discussion: This trial will provide data on the effectiveness, cost-effectiveness, and safety of antibacterial therapeutic clothing for patients with AD. Trial registration: ClinicalTrials.gov NCT04297215. Registered on 5 March 2020

Original languageEnglish
Article number902
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 11 Dec 2021

Bibliographical note

Funding Information:
This study is funded by ZonMw, the Netherlands Organization for Health Research and Development, (project number 843004017) under the auspices of the Ministry of Health, Welfare and Sport and the National Health Care Institute of the Netherlands. In addition, the Department of Dermatology of the Erasmus MC University Medical Centre Rotterdam received an unrestricted grant from BAP Medical, D&M B.V., and DeclaCare (part of BENU Netherlands).

Funding Information:
We would like to acknowledge the Dutch?Society of Dermatology and Venerology (NVDV), Dutch Association for People with Atopic Dermatitis (VMCE), the Dutch National Health Care?Institute (ZorgInstituut)?and the Netherlands Organization for Health Research and Development (ZonMw) for there support.?In addition, we would like to thank Drs. Peter Zweipfenning?for his contribution to the?urinary?silver analyses. The first patient was included in the study in March 2020. Patient recruitment at several sites is currently temporarily halted because of the SARS-CoV-2 pandemic. Completion of the study is expected in October 2022.

Publisher Copyright:
© 2021, The Author(s).

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