Evidence map›Paper›PMID 34895292›Full record

ArticleTrials2021

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 and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04297215 (Pragmatic Randomized Controlled 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 Atopic Dermatitis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04297215 naunknown statusnot on this map

Pragmatic Randomized Controlled 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 Atopic Dermatitis

TypeinterventionalSponsorErasmus Medical CenterRan2020 to 2023Enrolled165ConditionsAtopic DermatitisArmsDermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing, Binamed® therapeutic clothing without antimicrobial agents
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Aviël RagaminDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Karin B Fieten *Dutch Asthma Center Davos, Davos, Switzerland.
Ron A Tupker *Department of Dermatology, Sint Antonius Hospital, 3435, CM, Nieuwegein, The Netherlands.
Jill de WitDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Minke M F van MierloDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Marieke S JansenDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Madelon B BronnerDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Renske SchappinDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Frank H J SchurenMicrobiology and Systems Biology, TNO, Zeist, The Netherlands.
Margreet L E RomeijnDepartment of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Bernd W M ArentsDutch Patient Association for People with Atopic Dermatitis (VMCE: Vereniging voor Mensen met Constitutioneel Eczeem), Nijkerk, The Netherlands.
Suzanne PolinderDepartment of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.
Marlies de GraafDepartment of Pediatric Dermatology and Allergology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Thomas RustemeyerDepartment of Dermatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
Marie L A SchuttelaarDepartment of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Suzanne G M A PasmansDepartment of Dermatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands. s.pasmans@erasmusmc.nl.ORCID http://orcid.org/0000-0003-1018-4475
Erasmus MC · NLUniversity Medical Center Groningen · NLAmsterdam University Medical Centers · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Utrecht · NLUniversity of Zurich · CH

Funding

ZonMw 843004017
6 · The paper itself

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. DISCUSSION: This 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.

Indexed as

ChitosanDermatitis, AtopicAdultAnti-Bacterial AgentsChildClothingHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicSilverStaphylococcus aureusAnti-Bacterial AgentsChitosanSilverAntibacterialAtopic dermatitisRandomized controlled trialTherapeutic clothingTopical corticosteroidsTreatment

Identifiers

PMID34895292
PMCPMC8665308
OpenAlexW4226076662

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.