6. Needle-free electronically-controlled jet injector treatment with bleomycin and lidocaine is effective and welltolerated in patients with recalcitrant keloids. 153 6. RESULTS Patient characteristics A total of fifteen patients (eight female) with a median age of 28 (IQR 22−41) years and in total >148 keloids were included (Table 1). The majority of patients (73%, 11/15) had Fitzpatrick skin type three or four. All patients had an extensive treatment history, with at least multiple intralesional triamcinolone acetonide (TCA) treatments by CNIs. Treatment Fourteen out of 15 patients (93%) completed the course of three consecutive intralesional EPI assisted treatments and visited the outpatient clinic at a four to six weeks follow-up. One patient (7%) discontinued after two treatments due to a pregnancy wish. Most patients (80%, 12/15) were treated with a pressure ranging from 3 to 4 bar. In the remaining patients (20%, 3/15), a firmer keloid structure required a higher pressure of 4–5 bar to reach the clinical endpoint and achieve dermal distribution. The median interval between treatment was 5 weeks (IQR: 4–6) (Table S1). Effectiveness The POSAS observer scores and patient scores were significantly improved at follow-up compared to baseline (Table 2 and Figure 3). The median total POSAS observer score was 40 (IQR 29−51) at baseline, and the median paired difference at follow-up compared to baseline was −7 (−18%; IQR −11 to −3) points ( p < 0.001). Similarly, the median total POSAS patient score was 41 (IQR 37−47) at baseline, and the median paired difference at follow-up compared to baseline was −6 (−15%; IQR −13 to −3) points ( p < 0.001). The POSAS observer scale demonstrated a significant improvement in the subcategories “relief” and “overall opinion” ( p = 0.002; p = 0.019), while the POSAS patient scale showed a significant improvement in the subcategories “itch,” “stiffness,” and “thickness” ( p = 0.049; p = 0.006; p = 0.023). The GAIS score showed that 10 out of 14 patients (71%) exhibited “improved” or “very improved” treatment outcomes, and four out of 14 patients (29%) showed “unaltered” results (Table S2 and Figure 4).
RkJQdWJsaXNoZXIy MTk4NDMw