6. Needle-free electronically-controlled jet injector treatment with bleomycin and lidocaine is effective and welltolerated in patients with recalcitrant keloids. 150 MATERIALS AND METHODS Study design and population This retrospective cohort study was performed at the Department of Dermatology at Erasmus University Medical Center (Erasmus MC) in Rotterdam, The Netherlands from November 2022 until May 2023. All adult patients with the presence of ≥1 recalcitrant keloid scar defined as a history of suboptimal treatments (resistance to multiple intralesional TCA injections with conventional needle injectors (CNI) or EPI, needle phobia or needle pain) were eligible for inclusion. The Medical Ethical Research Committee of Erasmus MC in Rotterdam approved the study (MEC-2021-0661). STROBE guidelines were followed. Written informed consent was obtained from all patients for the anonymous use of their clinical data and photographs. Data collection and outcome measures Electronical medical records were used for data collection. The primary objective was to assess clinical effectiveness using the Patient and Observer Scar Assessment Scale (POSAS).21, 22 The POSAS score is a scar assessment tool that measures the quality of a scar.22 A local standard operating procedure (SOP) for EPI-assisted bleomycin treatment in adult patients with keloids was followed. According to this SOP, the POSAS was used to evaluate the keloids by the treating physicians (V. B.; P. A.) and patients during treatment regular visits to the outpatient clinic at baseline and four to six weeks after the third treatment. The POSAS score consists of six items concerning patient symptoms and clinical characteristics of the keloid. The patient and clinician can score the items from 1 (normal skin) to 10 (worst imaginable abnormality) points. The sum of these items gives the total POSAS score of minimum 6 and maximum of 60 points. The secondary objectives included tolerability, patient satisfaction and aesthetic appearance. These objectives were evaluated using treatment-related pain scores (numeric rating scale [NRS] range 0–10), adverse effects which were recorded at each visit by the treating physician, a patient satisfaction questionnaire and the Global Aesthetic Improvement Score (GAIS), respectively. The GAIS measures the improvement
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