The Editors thank the investigators for displaying tenacity, evidenced by the significant revisions that were necessary to complete this project. Their published study describes a randomized CO2 ablative laser treatment protocol, applied to pediatric burn scars [1]. It highlights challenges and provides readers with key learnings about the design and conduct of intervention trials during the post-burn rehabilitation phase, especially when investigating scar treatments for pediatric burn patients. This trial was diligently designed as a randomized, controlled, clinical intervention trial. However, the original trial was abandoned due to the negative impact of the COVID-19 pandemic on the ability to recruit ambulatory patients and carers, who were ultimately seeking an intervention to improve the symptoms and quality of their mature scars. It is worth reiterating that the investigators also note that motivation to join this study was likely impacted by the choice to apply CO2 ablative laser treatment under general anesthetic and to only half of the studied scar surface area.
After the pilot study, the investigators proceeded with the trial as a combined feasibility and pilot trial [2]. As this was not the initial intention, readers must consider the contextual factors in their interpretation of the presented results, because traditional feasibility and/or pilot trial assessments of the investigative process were applied ad hoc in this study [3,4]. The interpretation of the clinical results in the report must be approached with extreme caution and require further confirmation due to the heterogeneous, small sample including only female participants, spanning multiple developmental age stages and with scars at vastly different points of maturation. Based on this, specific caution must be applied in the interpretation of cluster analysis, again with respect to recruited numbers and repeated (scar) assessments, which were not available for all participants.
Conflicts of Interest
The authors declare no conflict of interest.
References
- Sinha, S.; Baykan, A.; Hulin, K.; Baron, D.; Gabriel, V.; Fraulin, F.O.G. Fractional CO2 Laser for Pediatric Hypertrophic Scars: Lessons Learned from a Prematurely Terminated Split-Scar Trial. Eur. Burn J. 2025, 6, 10. [Google Scholar] [CrossRef]
- Eldridge, S.M.; Lancaster, G.A.; Campbell, M.J.; Thabane, L.; Hopewell, S.; Coleman, C.L.; Bond, C.M. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE 2016, 11, e0150205. [Google Scholar] [CrossRef] [PubMed]
- Thabane, L.; Ma, J.; Chu, R.; Cheng, J.; Ismaila, A.; Rios, L.P.; Robson, R.; Thabane, M.; Giangregorio, L.; Goldsmith, C.H. A tutorial on pilot studies: The what, why and how. BMC Med. Res. Methodol. 2010, 10, 1. [Google Scholar] [CrossRef] [PubMed]
- Eldridge, S.M.; Chan, C.L.; Campbell, M.J.; Bond, C.M.; Hopewell, S.; Thabane, L.; Lancaster, G.A. CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. BMJ 2016, 355, i5239. [Google Scholar] [CrossRef] [PubMed]
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© 2025 by the authors. Published by MDPI on behalf of the European Burns Association. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).