6. Needle-free electronically-controlled jet injector treatment with bleomycin and lidocaine is effective and welltolerated in patients with recalcitrant keloids. 157 6. DISCUSSION In this study we show that-EPI assisted treatment with bleomycin and lidocaine is effective in patients with recalcitrant keloids and yielded significantly lower NRS pain scores compared to conventional needle injections. Total POSAS scores after three consecutive treatments were statistically significantly reduced compared to baseline, from both patient and observer perspectives. The sub-categories “itch,” “stiffness” and “thickness” were significantly improved according to the patients, while “pliability” and “overall opinion” with regard to keloid quality were significantly improved according to treating physicians, Only minor adverse effects were observed, of which local hyperpigmentation was most common. Patients were highly satisfied with their treatment and would recommend the treatment to others, presumably because of the reduced injection related pain. Previously, Bik et al.16 and Erlendson et al.25 investigated the effectiveness, tolerability, and patient satisfaction of intralesional EPI-assisted TCA and 5-Fluorouracil, respectively. Notably, in the study by Bik et al., patients who received intralesional TCA with an EPI for their keloids reported an average pain score of 4.3 during the first treatment, which exceeds the median pain score of 2.0 (IQR 1.5−2.5) observed in our study. The lower pain scores in our patients may be attributed to the use of a mixture of bleomycin with lidocaine. The local anesthetic lidocaine, acting as an additional pain-reducing treatment in conjunction with the jet injector, could lead to a remarkable reduction in procedurerelated pain (Table S3; NRS pain during needle-assisted bleomycin injection: 7.0). On the other hand, our findings with regard to pain scores show similarity to the findings of the randomized controlled study by Erlendson et al., in which also a median NRS pain score of 2.0 (IQR 2.0−2.0) was found, without the usage of lidocaine. However, in this study also patients with hypertrophic scars were included, which are usually less painful upon injection than (severe) keloids.26
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