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
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...
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| Format: | Article |
| Language: | English |
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BMC
2021-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05836-y |
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| author | 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 |
| author_facet | 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 |
| author_sort | Aviël Ragamin |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-17T21:08:15Z |
| format | Article |
| id | doaj.art-4135c000ec004b4d96a02ac7e4d615ae |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T21:08:15Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4135c000ec004b4d96a02ac7e4d615ae2022-12-21T21:32:31ZengBMCTrials1745-62152021-12-012211810.1186/s13063-021-05836-yThe 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 trialAviël Ragamin0Karin B. Fieten1Ron A. Tupker2Jill de Wit3Minke M. F. van Mierlo4Marieke S. Jansen5Madelon B. Bronner6Renske Schappin7Frank H. J. Schuren8Margreet L. E. Romeijn9Bernd W. M. Arents10Suzanne Polinder11Marlies de Graaf12Thomas Rustemeyer13Marie L. A. Schuttelaar14Suzanne G. M. A. Pasmans15Department of Dermatology, Erasmus MC, University Medical CenterDutch Asthma Center DavosDepartment of Dermatology, Sint Antonius HospitalDepartment of Dermatology, Erasmus MC, University Medical CenterDepartment of Dermatology, Erasmus MC, University Medical CenterDepartment of Dermatology, Erasmus MC, University Medical CenterDepartment of Dermatology, Erasmus MC, University Medical CenterDepartment of Dermatology, Erasmus MC, University Medical CenterMicrobiology and Systems Biology, TNODepartment of Dermatology, University Medical Center Groningen, University of GroningenDutch Patient Association for People with Atopic Dermatitis (VMCE: Vereniging voor Mensen met Constitutioneel Eczeem)Department of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Pediatric Dermatology and Allergology, Wilhelmina Children’s Hospital, University Medical Center UtrechtDepartment of Dermatology, Amsterdam University Medical CentresDepartment of Dermatology, University Medical Center Groningen, University of GroningenDepartment of Dermatology, Erasmus MC, University Medical CenterAbstract 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 2020https://doi.org/10.1186/s13063-021-05836-yAtopic dermatitisTherapeutic clothingAntibacterialTreatmentTopical corticosteroidsRandomized controlled trial |
| spellingShingle | 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 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 Trials Atopic dermatitis Therapeutic clothing Antibacterial Treatment Topical corticosteroids Randomized controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Atopic dermatitis Therapeutic clothing Antibacterial Treatment Topical corticosteroids Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05836-y |
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