5. Needle-free electronically-controlled jet injector treatment with bleomycin is efficacious and well-tolerated in patients with severe keloids: results of a randomized, double-blind, placebo-controlled trial. 130 A theoretical limitation of this study includes a cross-over effect of bleomycin treatment from one side of the lesion to the other side of the split-lesion in larger keloids (≥ 4 cm). Therefore, in all divided keloids an exclusion zone of 1 cm was respected to minimize the potential cross-over effect. Additionally, our study is constrained by a relatively short follow-up time, which limits the evaluation of recurrences. However, a previous metaanalysis has shown already that recurrence rates with bleomycin are low, and therefore we did not prioritize a longer follow-up time.32 Another limitation is the substantial residual fluid (≈ 50% of the injected volume) observed on the skin after EPI treatments, which was higher than previously reported in other studies (≈ 10-20% of the injected volume).30,33 This might be related to the rigid nature of the severe keloids that were included in this study that were more difficult to penetrate with EPI. Our results indicate that intralesional EPI-assisted bleomycin administration is a promising treatment modality for patients with severe keloids. However, since there is a small risk for local adverse events such as transient necrosis, we believe it should primarily be considered if standard of care (intralesional TCA) fails or leads to quick recurrences. Furthermore, intralesional bleomycin cannot be used in pregnant or lactating women, and therefore extra caution is needed when selecting patients for this treatment. Moreover, when performing EPI-assisted intralesional bleomycin treatment, it is important to use protective safety measures such as smoke evacuators and face masks to prevent the inhalation of potentially harmful bleomycin aerosols by patients and practitioners.34 Future technical innovation of EPI devices may lead to more efficient, more precise and less painful drug delivery with minimal residue formation. However, until this next generation of devices arrives, addition of local anesthetics such as lidocaine may be considered for decreasing the procedure related pain. To conclude, in this study we demonstrated that three monthly EPI treatments with bleomycin significantly decreased keloid volume, keloid related symptoms, and was preferred over needle injection by patients with severe keloids. A well-powered
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