8. General discussion 205 8. lesions (p = 0.54). Because injection related pain scores were also high in the placebo treated lesions, we concluded that these high injection-related pain scores may be inherent to this severely affected population who suffer from severe keloids of which some were already painful upon palpation. However, we still hypothesized that the usage of a needle-free EPI was clinically meaningful because the majority of patients preferred EPI over conventional needles. Based on the results of this study, we decided to add lidocaine to the EPI-assisted treatment with bleomycin in the subsequent real-world study. The results of this study are shown in chapter 6. The POSAS patient- and observerscores were respectively 41 and 40 at baseline, and reduced with respectively 6 and 7points at follow-up (p < 0.001; p < 0.001). Moreover, we found that the addition of lidocaine to bleomycin was beneficial, since it leads to minimal injections related pain scores (NRS pain 2.0 (IQR 1.5−2.5)). Adverse events were mild and included hyperpigmentation, transient local pain, sensitivity or itching, hematoma, scab formation and acneiform inflammation of the keloid. All patients preferred EPI treatment over treatment with needles. This study shows similarity to the study of Bik et al. In this study the effectiveness, tolerability, and patient satisfaction of intralesional EPI-assisted TCA were investigated.18 In this cohort study injection related NRS pain scores were assessed as slightly more painful (mean NRS pain 4.3 ± 1.9), and adverse events were hematoma, local itching, mild skin atrophy, superficial deposition of TCA, and transient pain, sensitivity or burning. Unlike observed in studies that investigated bleomycin treatment, no necrosis occurred.
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