Title
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
Author
Ragamin, A.
Fieten, K.B.
Tupker, R.A.
de Wit, J.
van Mierlo, M.M.F.
Jansen, M.S.
Bronner, M.B.
Schappin, R.
Schuren, F.H.J.
Romeijn, M.L.E.
Arents, B.W.M.
Suzanne,
Polinder, S.
de Graaf, M.
Rustemeyer, T.
Schuttelaar, M.L.A.
Pasmans, S.G.M.A.
Publication year
2021
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 © 2021, The Author(s).
Subject
Antibacterial
Atopic dermatitis
Randomized controlled trial
Therapeutic clothing
Topical corticosteroids
Treatment
To reference this document use:
http://resolver.tudelft.nl/uuid:4a34e49c-ecac-4724-b4b3-f814c39569d2
DOI
https://doi.org/10.1186/s13063-021-05836-y
TNO identifier
962204
Report number
TNO 2022 P10022
Source
Trials, 22 (22)
Document type
article