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.

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].

Comparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: a protocol for a randomised controlled trial.

INTRODUCTION: Peripheral intravenous catheters (PIVCs) frequently fail during therapy administration, resulting in infusates pooling in the surrounding tissue. These extravasation injuries can cause significant pain, tissue destruction and scarring. ivWatch is a biosensor that uses visible and near-infrared light to measure tissue changes surrounding the PIVC and alert clinicians when extravasation may occur. The effectiveness of ivWatch, in comparison to clinical observation, in decreasing injury severity is unknown. The present study aims to investigate whether using ivWatch may potentially detect injury earlier and decrease the severity of PIVC extravasation injuries. METHODS AND ANALYSIS: A single centre, parallel group, open-label superiority randomised controlled trial comparing (a) standard care (clinical observation) to (b) ivWatch monitoring in addition to standard care, to decrease the severity of extravasation injuries. 200 children with PIVCs inserted in the distal half of the limb, receiving intermediate-risk to high-risk infusates for ≥24 hours, will be consecutively recruited at a paediatric intensive care unit in Queensland, Australia. The primary outcome is extravasation severity, measured by the Cincinnati Children's Extravasation Harm Scale. Secondary outcomes include severity assessed with three-dimensional camera imaging, extravasation volume, treatment sequelae, the number of PIVCs used and dwell time, quality of life and healthcare costs. The between treatment difference in extravasation severity will be compared using ordinal logistic regression, with the treatment group included as the main effect, and reported with corresponding 95% CIs. Estimates of value will be presented as net monetary benefits and cost per reduction in extravasation injury severity, both presented with corresponding 95% credible intervals. ETHICS AND DISSEMINATION: This study received approval from the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (reference number: HREC/20/QCHQ/60867) and the Griffith University HREC (reference number: 2020/310) and will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12620000317998.

What to measure in biliary atresia research: study protocol for developing a core outcome set.

AIM: Extrahepatic biliary atresia is a rare disorder. This creates challenges in the quality and quantity of research conducted. This issue is exacerbated by the potential heterogeneity in the reported outcomes in research examining the management of biliary atresia. A core outcome set is required to standardise reporting on the management of biliary atresia in research, facilitate systematic reviews that include outcomes of greatest importance to patients and clinicians, and to evaluate the quality of the existing evidence base on the management of biliary atresia. METHODS: A list of all potential outcomes will be developed through a systematic review of the literature. This list will be refined through a three-stage Delphi approach, involving key stakeholders in the management of biliary atresia. This will include patients and their parents, clinicians, nurses and allied health professionals. In this way, outcomes will be prioritised into a set of consensus core outcomes. CONCLUSION: The development of a core outcome set in biliary atresia management is needed to guide future research and assist in evaluating the quality of existing research. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC), Ref: HREC/20/QCHQ/62448. Results of the study will be published in an open access format.