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. 120 unblinded pharmacist that prepared identical syringes, with either bleomycin or physiological saline. Blinding was ensured until data was locked. Intervention For each lesion, a transparent sheet was consistently used, indicating "lesion 1" and "lesion 2." To prevent a carry-over effect, an exclusion zone of 1 cm was respected between the lesions (Figure S1). A physician blinded to treatment administered three treatments every 28 days. Each treatment consisted of intralesional bleomycin in one lesion and physiological saline in the other lesion, using an EPI (Enerjet 2.0; Sinclair Pharma, Rehovot, Israel). This device contained a 10 ml syringe and a 200 μm nozzle. Approximately every square centimeter of the included keloid lesion received one intralesional injection. Each injection volume was 100 μl, delivered with a starting pressure of 3 bar and (device range 50–150μl; 2-6 bar). Pressure ranged from 3 – 5 bar depending on the scar characteristics, and was increased with 10% if the clinical endpoint (papule or blanching) was not observed after injection. In each keloid lesion 1 USP/ml of bleomycin (Bleomedac, Pharmanovia Benelux, Breda, The Netherlands) was delivered, while in the control lesion NaCl 0.9% was delivered. The syringes with bleomycin could not be distinguished from the syringes with NaCl. A maximum dose of 2 USP bleomycin was administered per treatment. Primary and secondary outcomes The primary outcome was change in keloid volume. Secondary outcomes included change in height, Patient and Observer Scar Assessment Scale (POSAS), change in perfusion, spilled volume during treatment, procedure related pain scores, adverse events and patient satisfaction. All outcome measures were assessed at all three treatment visits and at follow-up (week 12, four weeks after the third treatment).
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