A randomised investigation of film-forming silicone gel in superficial partial thickness face and neck burn patients: Indication of improved early scar pigmentation outcomes.

Burns to the face and neck are a source of considerable distress and a challenge to manage with dressings. Further, these often superficial injuries pose a risk of scarring and altered pigmentation. Silicone gels have emerged as a potential solution to the challenges of conservative management for face and neck burn injuries. The aims of this study were to explore the effect of topical silicone compared to routine treatment of conservatively managed burns to the face and neck. This single-blind, randomised, controlled trial compared topical silicone film-forming dressing to standard of care for superficial partial thickness burns to the face and neck. Time to healing was the primary outcome and secondary outcomes included: 1) scar assessments (modified Vancouver Scar Scale, Dermalab Combo and Patient and Observer Scar Assessment Scale) at six weeks and three months; and 2) pain intensity scale at wound review appointments. Of the 55 participants in the face/neck study, 34 were male and 21 were female. Median age was 36 years (range from 25 to 47 years). The median time to healing for the silicone group was 9 days (CI 7.6 -10.4) and the control group was 7 days (CI 5.3- 8.7), p = 0.056. Analysis demonstrated significantly reduced pigmentation at six weeks in mVSS scores for the silicone group (Md = 0, IQR = 0) compared to the control group (Md = 0, IQR = 0 - 3), p = 0.043. We found no evidence of differences in reported pain between the groups (Silicone - Md = 1.15, IQR 0.3 - 4.5 vs control group - Md = 1.5, IQR 0.6 - 3.8, z = -0.63, p = 0.53). No other differences were observed, and no adverse events were associated with the topical silicone in the study whereas an infection and a reaction were experienced in the control group. Film-forming silicone gel had comparable effects to standard of care emollient on wound healing of superficial partial thickness burns of the face and neck. Silicone treated wounds were associated with a significant improvement in scar pigmentation outcome at six weeks post-burn.

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Declaration of Competing Interest All authors warrant that they have no competing interests to declare with respect to this study and the findings stated herein with integrity. Ms Poelchow’s involvement in the study was funded at arm’s length by Stratpharma AG and was in partial fulfilment of requirements for her Masters of Philosophy award (conferred 2023, The University of Notre Dame Australia). Stratpharma AG scientific advisors and representatives were consulted during the design of the study; were not involved in the conduct of the study or collection of data and outcomes; and, did not have access to raw data. Stratpharma AG representatives and advisors were given opportunity to review the manuscript and provide their feedback on the wording of the report text only after independent interpretation. The interpretation of raw data and results was conducted solely by the clinicians and academic supervisors.