Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol

Oxford University Press (OUP) - Tập 7 - 2019
Anjana Bairagi1,2, Bronwyn Griffin1,2, Zephanie Tyack3,4, Dimitrios Vagenas5, Steven McPhail3,6, Roy Kimble1,2,4
1Pegg Leditschke Children’s Burns Centre Queensland Children’s Hospital Brisbane, Queensland, Australia
2School of Nursing, Institute of Health and Biomedical Innovation Queensland University of Technology Brisbane, Queensland, Australia
3Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, School of Public Health and Social Work Queensland University of Technology Brisbane, Queensland, Australia
4The University of Queensland, Brisbane, Queensland, Australia
5Research Methods Group, Institute of Health and Biomedical Innovation Queensland University of Technology Brisbane, Queensland, Australia
6Centre for Functioning and Health Research, Metro South Hospital and Health Service, Brisbane, Queensland, Australia

Tóm tắt

Abstract Background Mixed partial thickness burns are the most common depth of burn injury managed at a large Australian paediatric hospital specialty burns unit. Prolonged time until re-epithelialisation is associated with increased burn depth and scar formation. Whilst current wound management approaches have benefits such as anti-microbial cover, these are not without inherent limitations including multiple dressing changes. The Biobrane® RECELL® Autologous skin Cell suspension and Silver dressings (BRACS) trial aims to identify the most effective wound management approach for mixed partial thickness injuries in children. Methods All children presenting with an acute burn injury to the study site will be screened for eligibility. This is a single-centre, three-arm, parallel group, randomised trial. Children younger than 16 years, with burns ≥ 5% total body surface area involving any anatomical location, up to 48 h after the burn injury, and of a superficial partial to mid-dermal depth, will be included. A sample size of 84 participants will be randomised to standard silver dressing or a Regenerative Epithelial Suspension (RES™) with Biobrane® or Biobrane® alone. The first dressing will be applied under general anaesthesia and subsequent dressings will be changed every 3 to 5 days until the wound is ≥ 95% re-epithelialised, with re-epithelialisation time the primary outcome. Secondary outcomes of acute pain, acute itch, scar severity, health-related quality of life, treatment satisfaction, dressing application ease and healthcare resource use will be assessed at each dressing change and 3, 6 and 12 months post-burn injury. Discussion The findings of this study can potentially change the wound management approach for superficial partial to mid-dermal burns in children locally and worldwide. Trial registration The Australian New Zealand Clinical Trials Registry (ACTRN12618000245291) approved prospective registration on 15 February 2018. Registration details can be viewed at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374272&isReview=true.

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Tài liệu tham khảo

Peck, 2012, Epidemiology and prevention of burns throughout the world. Jeschke MG, Kamolz L-P, Sjöberg F, Wolf SE, editors

Simons, 2016, Patient experiences of burn scars in adults and children and development of a health-related quality of life conceptual model: a qualitative study, Burns., 42, 620, 10.1016/j.burns.2015.11.012

De Young, 2012, Prevalence, comorbidity and course of trauma reactions in young burn-injured children, J Child Psychol Psychiatry, 53, 56, 10.1111/j.1469-7610.2011.02431.x

Maskell, 2013, Psychosocial functioning differences in pediatric burn survivors compared with healthy norms, J Burn Care Res, 34, 465, 10.1097/BCR.0b013e31827217a9

Hop, 2014, Costs of burn care: a systematic review, Wound Repair Regen, 22, 436, 10.1111/wrr.12189

Tracy, 2017, BRANZ 8th Annual Report_ Jul 16 - Jun 17. Burns registry of Australia and New Zealand

Ter Horst, 2018, Advances in keratinocyte delivery in burn wound care, Adv Drug Deliv Rev, 123, 18, 10.1016/j.addr.2017.06.012

Watt, 2018, Stem cells, niches and scaffolds: applications to burns and wound care, Adv Drug Deliv Rev, 123, 82, 10.1016/j.addr.2017.10.012

Gee Kee, 2015, Randomized controlled trial of three burns dressings for partial thickness burns in children, Burns., 41, 946, 10.1016/j.burns.2014.11.005

Wood, 2012, A prospective randomised clinical pilot study to compare the effectiveness of Biobrane(R) synthetic wound dressing, with or without autologous cell suspension, to the local standard treatment regimen in paediatric scald injuries, Burns., 38, 830, 10.1016/j.burns.2011.12.020

Mandal, 2007, Paediatric partial-thickness scald burns–is Biobrane the best treatment available?, Int Wound J, 4, 15, 10.1111/j.1742-481X.2006.00279.x

Lesher, 2011, Effectiveness of Biobrane for treatment of partial-thickness burns in children, J Pediatr Surg, 46, 1759, 10.1016/j.jpedsurg.2011.03.070

Lonie, 2017, Healing time and incidence of hypertrophic scarring in paediatric scalds, Burns., 43, 509, 10.1016/j.burns.2016.09.011

Gee Kee, 2017, Cost-effectiveness of silver dressings for paediatric partial thickness burns: an economic evaluation from a randomized controlled trial, Burns., 43, 724, 10.1016/j.burns.2016.09.018

Deitch, 1983, Hypertrophic burn scars: analysis of variables, J Trauma, 23, 895, 10.1097/00005373-198310000-00009

Cubison, 2006, Evidence for the link between healing time and the development of hypertrophic scars (HTS) in paediatric burns due to scald injury, Burns., 32, 992, 10.1016/j.burns.2006.02.007

Chipp, 2017, A prospective study of time to healing and hypertrophic scarring in paediatric burns: every day counts, Burns Trauma, 5, 3, 10.1186/s41038-016-0068-2

Ketchum, 1977, Hypertrophic scars and keloids, Clin Plast Surg, 4, 301, 10.1016/S0094-1298(20)30584-8

Vloemans, 2014, Optimal treatment of partial thickness burns in children: a systematic review, Burns., 40, 177, 10.1016/j.burns.2013.09.016

Liu, 2017, History and Advancement of Burn Treatments, Annals of Plastic Surgery, 78, S2, 10.1097/SAP.0000000000000896

Cuttle, 2007, A retrospective cohort study of Acticoat versus Silvazine in a paediatric population, Burns., 33, 701, 10.1016/j.burns.2007.02.012

Khundkar, 2010, Use of Acticoat dressings in burns: what is the evidence?, Burns., 36, 751, 10.1016/j.burns.2009.04.008

Hajska, 2017, Cytotoxicity testing of burn wound dressings: first results, Cell Tissue Bank, 18, 143, 10.1007/s10561-017-9621-x

White, 2009, Mepitel: a non-adherent wound dressing with Safetac technology, Br J Nurs, 18, 58, 10.12968/bjon.2009.18.1.93582

Silverstein, 2011, An open, parallel, randomized, comparative, multicenter study to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (intervention) vs silver sulfadiazine cream, J Burn Care Res, 32, 617, 10.1097/BCR.0b013e318236fe31

Zhao, 2016, Autologous epidermal cell suspension: a promising treatment for chronic wounds, J Tissue Viability, 25, 50, 10.1016/j.jtv.2015.11.003

Wood, 2003, Clinical potential of autologous epithelial suspension, Wounds, 15, 16

Fan, 2018, Biobrane dressing for paediatric burns in Singapore: a retrospective review, Singap Med J, 59, 360, 10.11622/smedj.2017116

Gravante, 2007, A randomized trial comparing ReCell system of epidermal cells delivery versus classic skin grafts for the treatment of deep partial thickness burns, Burns., 33, 966, 10.1016/j.burns.2007.04.011

Holmes Iv, 2018, A comparative study of the ReCell(R) device and autologous spit-thickness meshed skin graft in the treatment of acute burn injuries, J Burn Care Res, 39, 694, 10.1093/jbcr/iry029

Dunne, 2014, Early paediatric scald surgery—a cost effective dermal preserving surgical protocol for all childhood scalds, Burns., 40, 777, 10.1016/j.burns.2013.11.011

Austin, 2015, A comparison of Biobrane and cadaveric allograft for temporizing the acute burn wound: cost and procedural time, Burns., 41, 749, 10.1016/j.burns.2014.10.003

Greenwood, 2009, Experience with biobrane: uses and caveats for success, Eplasty., 9

Hyland, 2018, Biobrane (TM) versus acticoat (TM) for the treatment of mid-dermal pediatric burns: a prospective randomized controlled pilot study, Int J Burns Trauma, 8, 63

Haddad, 2017, Skin substitutes and bioscaffolds: temporary and permanent coverage, Clin Plast Surg, 44, 627, 10.1016/j.cps.2017.02.019

Woodruff, 1984, Biobrane, a Biosynthetic Skin Prosthesis in Burn Wound Coverings. DL W, editor, c1984

Demling, 1995, Use of Biobrane in the management of scalds, J Burn Care Rehabil, 16, 329, 10.1097/00004630-199505000-00021

Phillips, 1989, Uses and abuses of a biosynthetic dressing for partial skin thickness burns, Burns., 15, 254, 10.1016/0305-4179(89)90044-2

Lal, 2000, Biobrane® improves wound healing in burned children without increased risk of infection, Shock., 14, 314, 10.1097/00024382-200014030-00013

Government, 2018, Queensland population counter: The State of Queensland (Queensland Treasury)

Farrar, 2017, Three-dimensional wound mapping software compared to expert opinion in determining wound area, Burns., 43, 1736, 10.1016/j.burns.2017.05.015

Fontaine, 2018, The e-burn application - a simple mobile tool to assess TBSA of burn wounds, Burns., 44, 237, 10.1016/j.burns.2017.09.020

2015, NSW Trauma App Analysis Report 21st August - 8th November 2015. Institute of Trauma and Injury Management

2016, NSW Trauma App Analysis Report August 2015 – August 2016. NSW Institute of Trauma and Injury Management

Holland, 2002, Laser Doppler imaging prediction of burn wound outcome in children, Burns., 28, 11, 10.1016/S0305-4179(01)00064-X

La Hei, 2006, Laser Doppler imaging of paediatric burns: burn wound outcome can be predicted independent of clinical examination, Burns., 32, 550, 10.1016/j.burns.2005.11.014

Cho, 2009, Relationship between healing time and mean perfusion units of laser Doppler imaging (LDI) in pediatric burns, Burns., 35, 818, 10.1016/j.burns.2008.12.009

Mileski, 2003, Serial measurements increase the accuracy of laser Doppler assessment of burn wounds, J Burn Care Rehabil, 24, 187, 10.1097/01.BCR.0000076091.79370.56

Jeng, 2003, Laser Doppler imaging determines need for excision and grafting in advance of clinical judgment: a prospective blinded trial, Burns., 29, 665, 10.1016/S0305-4179(03)00078-0

Mill, 2009, Laser Doppler imaging in a paediatric burns population, Burns., 35, 824, 10.1016/j.burns.2008.11.016

Wang, 2010, Ultrasound assessed thickness of burn scars in association with laser Doppler imaging determined depth of burns in paediatric patients, Burns., 36, 1254, 10.1016/j.burns.2010.05.018

Bloemen, 2012, Digital image analysis versus clinical assessment of wound epithelialization: a validation study, Burns., 38, 501, 10.1016/j.burns.2012.02.003

Bloemen, 2011, Reliability of subjective wound assessment, Burns., 37, 566, 10.1016/j.burns.2011.02.004

Stockton, 2015, 3D photography is as accurate as digital planimetry tracing in determining burn wound area, Burns., 41, 80, 10.1016/j.burns.2014.04.022

Gee Kee, 2015, 3D photography is a reliable burn wound area assessment tool compared to digital planimetry in very young children, Burns., 41, 1286, 10.1016/j.burns.2015.01.020

Page, 2012, Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time, J Pain, 13, 359, 10.1016/j.jpain.2011.12.010

von Baeyer, 2009, Three new datasets supporting use of the numerical rating scale (NRS-11) for children’s self-reports of pain intensity, Pain., 143, 223, 10.1016/j.pain.2009.03.002

Merkel, 1994, FLACC Pain Assessment Tool: Reliability and Validation with Existing Tools, Anesthesiology, 81, A1360, 10.1097/00000542-199409001-01359

von Baeyer, 2007, Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years, Pain., 127, 140, 10.1016/j.pain.2006.08.014

Huguet, 2010, Measurement of self-reported pain intensity in children and adolescents, J Psychosom Res, 68, 329, 10.1016/j.jpsychores.2009.06.003

Reich, 2011, New Data on the Validation of Vas and Nrs in Pruritus Assessment: Minimal Clinically Important Difference and Itch Frequency Measurement, Acta Derm Venereol, 91, 636, 10.2340/00015555-1129

Nieuwendijk, 2018, Post burn pruritus in pediatric burn patients, Burns., 44, 1151, 10.1016/j.burns.2018.02.022

Draaijers, 2003, The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation, Plast Reconstr Surg, 113, 1960, 10.1097/01.PRS.0000122207.28773.56

Tyack, 2017, Psychometric properties of the Brisbane burn scar impact profile in adults with burn scars, PLoS One, 12, e0184452, 10.1371/journal.pone.0184452

Tyack, 2015, Measuring the impact of burn scarring on health-related quality of life: development and preliminary content validation of the Brisbane burn scar impact profile (BBSIP) for children and adults, Burns., 41, 1405, 10.1016/j.burns.2015.05.021

Simons, 2017, Ultrasound is a reproducible and valid tool for measuring scar height in children with burn scars: a cross-sectional study of the psychometric properties and utility of the ultrasound and 3D camera, Burns., 43, 993, 10.1016/j.burns.2017.01.034

Draaijers, 2004, Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation?, Burns., 30, 103, 10.1016/j.burns.2003.09.029

Stevens, 2010, Working with children to develop dimensions for a preference-based, generic, pediatric health-related quality-of-life measure, Qual Health Res, 20, 340, 10.1177/1049732309358328

Stevens, 2009, Developing a descriptive system for a new preference-based measure of health-related quality of life for children, Qual Life Res, 18, 1105, 10.1007/s11136-009-9524-9

Stevens, 2011, Assessing the performance of a new generic measure of health related quality of life for children and refining it for use in health state valuation, Appl Health Econ Health Policy, 9, 157, 10.2165/11587350-000000000-00000

Stevens, 2010, The Child Health Utility 9D (CHU9D) – A New Paediatric Preference Based Measure of Health Related Quality of Life, PRO Newsletter, 43, 11

Revicki, 2004, Patient assessment of treatment satisfaction: methods and practical issues, Gut, 53, iv40

Willebrand, 2018, Parents’ perceived quality of pediatric burn care, J Crit Care, 43, 256, 10.1016/j.jcrc.2017.08.037

Lakatos, 1988, Sample Sizes Based on the Log-Rank Statistic in Complex Clinical Trials, Biometrics, 44, 229, 10.2307/2531910

Lakatos, 2002, Designing Complex Group Sequential Survival Trials, Stat Med, 21, 1969, 10.1002/sim.1193

Snow, 2013, blockrand: Randomization for block random clinical trials

Harris, 2009, Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform, 42, 377, 10.1016/j.jbi.2008.08.010

Chan, 2013, SPIRIT 2013 statement: defining standard protocol items for clinical trials, Ann Intern Med, 158, 200, 10.7326/0003-4819-158-3-201302050-00583

Chan, 2013, SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials, BMJ., 346, e7586, 10.1136/bmj.e7586

Brown, 2014, Predictors of re-epithelialization in pediatric burn, Burns., 40, 751, 10.1016/j.burns.2013.09.027

McGarry, 2016, Mental health and itch in burns patients: potential associations, Burns., 42, 763, 10.1016/j.burns.2016.01.010

Moher, 2010, CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials, J Clin Epidemiol, 63, e1, 10.1016/j.jclinepi.2010.03.004

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