Comment from the Enhancing Burn Rehabilitation Special Edition Editors on “Fractional CO2 Laser for Pediatric Hypertrophic Scars: Lessons Learned from a Prematurely Terminated Split-Scar Trial”
Dale W. Edgar, Colleen M. Ryan, Marianne K. Nieuwenhuis, Ulrike Van Daele, Jill M. Cancio

Abstract
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Taxonomy
TopicsBurn Injury Management and Outcomes · Wound Healing and Treatments · Diagnosis and Treatment of Venous Diseases
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 CO_2_ 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 CO_2_ 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.
The reference list from the paper itself. Each links out to its DOI / PubMed record.
- 1Sinha S. Baykan A. Hulin K. Baron D. Gabriel V. Fraulin F.O.G. Fractional CO 2 Laser for Pediatric Hypertrophic Scars: Lessons Learned from a Prematurely Terminated Split-Scar Trial Eur. Burn J.202561010.3390/ebj 601001040137006 PMC 11941394 · doi ↗ · pubmed ↗
- 2Eldridge 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 P Lo S ONE 201611 e 015020510.1371/journal.pone.015020526978655 PMC 4792418 · doi ↗ · pubmed ↗
- 3Thabane 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.201010110.1186/1471-2288-10-120053272 PMC 2824145 · doi ↗ · pubmed ↗
- 4Eldridge 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 2016355 i 523910.1136/bmj.i 523927777223 PMC 5076380 · doi ↗ · pubmed ↗
