A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial

Eleanor F. Harrison; Rachel H. Haines; Fiona Cowdell; Tracey H. Sach; Taraneh Dean; Ian Pollock; Nigel P. Burrows; Hannah Buckley; Jonathan Batchelor; Hywel C. Williams; Sandra Lawton; Sara J. Brown; Lucy E. Bradshaw; Amina Ahmed; Alan A. Montgomery; Eleanor J. Mitchell; Kim S. Thomas

doi:10.1186/s13063-015-0921-9

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial

Eleanor F. Harrison, Rachel H. Haines, Fiona Cowdell, Tracey H. Sach, Taraneh Dean, Ian Pollock, Nigel P. Burrows, Hannah Buckley, Jonathan Batchelor, Hywel C. Williams, Sandra Lawton, Sara J. Brown, Lucy E. Bradshaw, Amina Ahmed, Alan A. Montgomery, Eleanor J. Mitchell, Kim S. Thomas^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

11 Citations (SciVal)

Original language	English
Article number	390
Journal	Trials
Volume	16
Issue number	1
DOIs	https://doi.org/10.1186/s13063-015-0921-9
Publication status	Published (VoR) - 2 Sept 2015

Funding

The CLOTHES Trial has been developed with support from the UK Dermatology Clinical Trials Network, and delivered with assistance from the National Institute for Health Research Comprehensive Local Research Network. This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 11/65/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health. Initial development of the CLOTHES Trial was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0407-10177). SJB is supported by a Wellcome Trust Fellowship and the Manknell Charitable Trust. Clothing used in the study has been kindly donated by two suppliers of silk garments; Espère Healthcare Ltd. and DreamSkin Health Ltd. However, these companies have had no involvement in the design, conduct or interpretation of study results. The trial is sponsored by the University of Nottingham and supported by the NIHR Clinical Research Network. The authors would also like to acknowledge the following: Members of CEBD patient panel and people who responded to our on-line survey to inform the design. National Eczema Society and Nottingham Eczema Support Group for Carers of Children with Eczema for advertising the trial. Nottingham CTU and UK Dermatology Clinical Trials Network.

Keywords

Atopic dermatitis
Atopic eczema
Clothing
Eczema
Fabric
RCT
Silk

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Harrison, E. F., Haines, R. H., Cowdell, F., Sach, T. H., Dean, T., Pollock, I., Burrows, N. P., Buckley, H., Batchelor, J., Williams, H. C., Lawton, S., Brown, S. J., Bradshaw, L. E., Ahmed, A., Montgomery, A. A., Mitchell, E. J., & Thomas, K. S. (2015). A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial. Trials, 16(1), Article 390. https://doi.org/10.1186/s13063-015-0921-9

@article{f49941a1e4a948e7af4154914b6a6b18,

title = "A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial",

keywords = "Atopic dermatitis, Atopic eczema, Clothing, Eczema, Fabric, RCT, Silk",

author = "Harrison, \{Eleanor F.\} and Haines, \{Rachel H.\} and Fiona Cowdell and Sach, \{Tracey H.\} and Taraneh Dean and Ian Pollock and Burrows, \{Nigel P.\} and Hannah Buckley and Jonathan Batchelor and Williams, \{Hywel C.\} and Sandra Lawton and Brown, \{Sara J.\} and Bradshaw, \{Lucy E.\} and Amina Ahmed and Montgomery, \{Alan A.\} and Mitchell, \{Eleanor J.\} and Thomas, \{Kim S.\}",

note = "Funding Information: The CLOTHES Trial has been developed with support from the UK Dermatology Clinical Trials Network, and delivered with assistance from the National Institute for Health Research Comprehensive Local Research Network. Funding Information: This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 11/65/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health. Initial development of the CLOTHES Trial was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0407-10177). SJB is supported by a Wellcome Trust Fellowship and the Manknell Charitable Trust. Clothing used in the study has been kindly donated by two suppliers of silk garments; Esp{\`e}re Healthcare Ltd. and DreamSkin Health Ltd. However, these companies have had no involvement in the design, conduct or interpretation of study results. The trial is sponsored by the University of Nottingham and supported by the NIHR Clinical Research Network. The authors would also like to acknowledge the following: Members of CEBD patient panel and people who responded to our on-line survey to inform the design. National Eczema Society and Nottingham Eczema Support Group for Carers of Children with Eczema for advertising the trial. Nottingham CTU and UK Dermatology Clinical Trials Network. Publisher Copyright: {\textcopyright} 2015 Harrison et al.",

year = "2015",

month = sep,

day = "2",

doi = "10.1186/s13063-015-0921-9",

language = "English",

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Harrison, EF, Haines, RH, Cowdell, F, Sach, TH, Dean, T, Pollock, I, Burrows, NP, Buckley, H, Batchelor, J, Williams, HC, Lawton, S, Brown, SJ, Bradshaw, LE, Ahmed, A, Montgomery, AA, Mitchell, EJ & Thomas, KS 2015, 'A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial', Trials, vol. 16, no. 1, 390. https://doi.org/10.1186/s13063-015-0921-9

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial. / Harrison, Eleanor F.; Haines, Rachel H.; Cowdell, Fiona et al.
In: Trials, Vol. 16, No. 1, 390, 02.09.2015.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial)

T2 - Study protocol for a randomised controlled trial

AU - Harrison, Eleanor F.

AU - Haines, Rachel H.

AU - Cowdell, Fiona

AU - Sach, Tracey H.

AU - Dean, Taraneh

AU - Pollock, Ian

AU - Burrows, Nigel P.

AU - Buckley, Hannah

AU - Batchelor, Jonathan

AU - Williams, Hywel C.

AU - Lawton, Sandra

AU - Brown, Sara J.

AU - Bradshaw, Lucy E.

AU - Ahmed, Amina

AU - Montgomery, Alan A.

AU - Mitchell, Eleanor J.

AU - Thomas, Kim S.

N1 - Funding Information: The CLOTHES Trial has been developed with support from the UK Dermatology Clinical Trials Network, and delivered with assistance from the National Institute for Health Research Comprehensive Local Research Network. Funding Information: This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 11/65/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health. Initial development of the CLOTHES Trial was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0407-10177). SJB is supported by a Wellcome Trust Fellowship and the Manknell Charitable Trust. Clothing used in the study has been kindly donated by two suppliers of silk garments; Espère Healthcare Ltd. and DreamSkin Health Ltd. However, these companies have had no involvement in the design, conduct or interpretation of study results. The trial is sponsored by the University of Nottingham and supported by the NIHR Clinical Research Network. The authors would also like to acknowledge the following: Members of CEBD patient panel and people who responded to our on-line survey to inform the design. National Eczema Society and Nottingham Eczema Support Group for Carers of Children with Eczema for advertising the trial. Nottingham CTU and UK Dermatology Clinical Trials Network. Publisher Copyright: © 2015 Harrison et al.

PY - 2015/9/2

Y1 - 2015/9/2

KW - Atopic dermatitis

KW - Atopic eczema

KW - Clothing

KW - Eczema

KW - Fabric

KW - RCT

KW - Silk

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U2 - 10.1186/s13063-015-0921-9

DO - 10.1186/s13063-015-0921-9

M3 - Article

C2 - 26329718

AN - SCOPUS:84940521246

SN - 1745-6215

VL - 16

JO - Trials

JF - Trials

IS - 1

M1 - 390

ER -

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): Study protocol for a randomised controlled trial

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Keywords

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