Effectiveness of a Regenerative Epithelial Suspension (RES), on the pigmentation of split-thickness skin graft donor sites in children: the dRESsing pilot randomised controlled trial protocol

BackgroundPaediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients wi...

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Published inBMJ open Vol. 14; no. 2; p. e077525
Main Authors Bairagi, Anjana, Tyack, Zephanie, Kimble, Roy M, McPhail, Steven M, McBride, Craig Antony, Patel, Bhaveshkumar, Vagenas, Dimitrios, Dettrick, Zoe, Griffin, Bronwyn
Format Journal Article
LanguageEnglish
Published London British Medical Journal Publishing Group 27.02.2024
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesProtocol
Subjects
Clinical trials
Data collection
General anesthesia
Intervention
Paediatric plastic & reconstructive surgery
Pediatrics
Plastic surgery
Scars
Skin & tissue grafts
Surgeons
Surgery
Transplant surgery
Trauma management
WOUND MANAGEMENT
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Abstract BackgroundPaediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients with vitiligo, and in adult patients following a burn injury. Very little is known regarding the efficacy of RES for the management of donor site scars in children.Methods and analysisA pilot randomised controlled trial of 40 children allocated to two groups (RES or no RES) standard dressing applied to donor site wounds will be conducted. All children aged 16 years or younger requiring a split thickness skin graft will be screened for eligibility. The primary outcome is donor site scar pigmentation 12 months after skin grafting. Secondary outcomes include re-epithelialisation time, pain, itch, dressing application ease, treatment satisfaction, scar thickness and health-related quality of life. Commencing 7 days after the skin graft, the dressing will be changed every 3–5 days until the donor site is ≥ 95% re-epithelialised. Data will be collected at each dressing change and 3, 6 and 12 months post skin graft.Ethics and disseminationEthics approval was confirmed on 11 February 2019 by the study site Human Research Ethics Committee (HREC) (HREC/18/QCHQ/45807). Study findings will be published in peer-reviewed journals and presented at national and international conferences. This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (available at https://anzctr.org.au/ACTRN12620000227998.aspx).Trial registration numberAustralian New Zealand Clinical Trials Registry [Available at https://anzctr.org.au/ACTRN12620000227998.aspx]
AbstractList BackgroundPaediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients with vitiligo, and in adult patients following a burn injury. Very little is known regarding the efficacy of RES for the management of donor site scars in children.Methods and analysisA pilot randomised controlled trial of 40 children allocated to two groups (RES or no RES) standard dressing applied to donor site wounds will be conducted. All children aged 16 years or younger requiring a split thickness skin graft will be screened for eligibility. The primary outcome is donor site scar pigmentation 12 months after skin grafting. Secondary outcomes include re-epithelialisation time, pain, itch, dressing application ease, treatment satisfaction, scar thickness and health-related quality of life. Commencing 7 days after the skin graft, the dressing will be changed every 3–5 days until the donor site is ≥ 95% re-epithelialised. Data will be collected at each dressing change and 3, 6 and 12 months post skin graft.Ethics and disseminationEthics approval was confirmed on 11 February 2019 by the study site Human Research Ethics Committee (HREC) (HREC/18/QCHQ/45807). Study findings will be published in peer-reviewed journals and presented at national and international conferences. This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (available at https://anzctr.org.au/ACTRN12620000227998.aspx).Trial registration numberAustralian New Zealand Clinical Trials Registry [Available at https://anzctr.org.au/ACTRN12620000227998.aspx]
Background Paediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients with vitiligo, and in adult patients following a burn injury. Very little is known regarding the efficacy of RES for the management of donor site scars in children.Methods and analysis A pilot randomised controlled trial of 40 children allocated to two groups (RES or no RES) standard dressing applied to donor site wounds will be conducted. All children aged 16 years or younger requiring a split thickness skin graft will be screened for eligibility. The primary outcome is donor site scar pigmentation 12 months after skin grafting. Secondary outcomes include re-epithelialisation time, pain, itch, dressing application ease, treatment satisfaction, scar thickness and health-related quality of life. Commencing 7 days after the skin graft, the dressing will be changed every 3–5 days until the donor site is ≥ 95% re-epithelialised. Data will be collected at each dressing change and 3, 6 and 12 months post skin graft.Ethics and dissemination Ethics approval was confirmed on 11 February 2019 by the study site Human Research Ethics Committee (HREC) (HREC/18/QCHQ/45807). Study findings will be published in peer-reviewed journals and presented at national and international conferences. This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (available at https://anzctr.org.au/ACTRN12620000227998.aspx).Trial registration number Australian New Zealand Clinical Trials Registry [Available at https://anzctr.org.au/ACTRN12620000227998.aspx]
Author Tyack, Zephanie
McPhail, Steven M
Dettrick, Zoe
Griffin, Bronwyn
Vagenas, Dimitrios
McBride, Craig Antony
Patel, Bhaveshkumar
Bairagi, Anjana
Kimble, Roy M
AuthorAffiliation 1 Centre for Children's Burns & Trauma Research and Pegg Leditschke Children's Burn Centre , Queensland Children's Hospital , Brisbane , Queensland , Australia
3 Burns and Trauma Research, Centre for Children’s Health Research , Queensland University of Technology , Brisbane , Queensland , Australia
5 Digital Health and Informatics , Metro South Health , Brisbane , Queensland , Australia
2 Australian Centre for Health Services Innovation (AusHSI), Centre for Healthcare Transformation , Queensland University of Technology , Brisbane , Queensland , Australia
4 The University of Queensland , Brisbane , Queensland , Australia
6 Research Methods Group , Queensland University of Technology , Brisbane , Queensland , Australia
7 Menzies Health Institute of Queensland , Griffith University , Brisbane , Queensland , Australia
AuthorAffiliation_xml – name: 2 Australian Centre for Health Services Innovation (AusHSI), Centre for Healthcare Transformation , Queensland University of Technology , Brisbane , Queensland , Australia
– name: 5 Digital Health and Informatics , Metro South Health , Brisbane , Queensland , Australia
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– name: 7 Menzies Health Institute of Queensland , Griffith University , Brisbane , Queensland , Australia
– name: 4 The University of Queensland , Brisbane , Queensland , Australia
– name: 1 Centre for Children's Burns & Trauma Research and Pegg Leditschke Children's Burn Centre , Queensland Children's Hospital , Brisbane , Queensland , Australia
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  surname: Vagenas
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  givenname: Zoe
  surname: Dettrick
  fullname: Dettrick, Zoe
  organization: Research Methods Group, Queensland University of Technology, Brisbane, Queensland, Australia
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  givenname: Bronwyn
  surname: Griffin
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  organization: Menzies Health Institute of Queensland, Griffith University, Brisbane, Queensland, Australia
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SSID ssj0000459552
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Snippet BackgroundPaediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can...
BACKGROUNDPaediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can...
Background Paediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can...
SourceID doaj
pubmedcentral
proquest
bmj
SourceType Open Website
Open Access Repository
Aggregation Database
Publisher
StartPage e077525
SubjectTerms Clinical trials
Data collection
General anesthesia
Intervention
Paediatric plastic & reconstructive surgery
Pediatrics
Plastic surgery
Scars
Skin & tissue grafts
Surgeons
Surgery
Transplant surgery
Trauma management
WOUND MANAGEMENT
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Title Effectiveness of a Regenerative Epithelial Suspension (RES), on the pigmentation of split-thickness skin graft donor sites in children: the dRESsing pilot randomised controlled trial protocol
URI https://bmjopen.bmj.com/content/14/2/e077525.full
https://www.proquest.com/docview/2932340705
https://search.proquest.com/docview/2933463699
https://pubmed.ncbi.nlm.nih.gov/PMC10900329
https://doaj.org/article/e1beac75a07a4a4e973519ef4cce6396
Volume 14
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