9. English and Dutch summaries 225 9. safety for the treatment of pathological scars, including keloid, hypertrophic scars and atrophic scars. However, the majority of these studies had moderate methodological quality. Therefore, there is a need for clinical studies with high methodological quality that investigate the effectiveness and safety of EPI in keloid. Chapter 3 shows the biodistribution of TCA administered via a needle-free jet injector and conventional needle in keloidal skin and healthy skin. The biodistribution was investigated in this study using an innovative imaging technique, the 3D-Fluorescent Imaging Cryomicrotome System (3D-FICS). This technique makes it possible to visualize the injected TCA in high resolution and 3D. The 3D technique offers the possibility to analyse the shape of the injected TCA. However, the shape of the injected fluid with both the needle and jet injectors was very heterogeneous, and no pattern could be recognized. The results of this study also showed that the heterogeneity of the injected volume in keloid with both jet injections and needle injections is greater compared to the injected volume of TCA in healthy skin. This could possibly explain the difference in effect between keloids with the same treatment. Chapter 4 describes, based on existing literature, which keloid-related characteristics can lead to recalcitrance. The results of this study showed that the location, duration, size, therapeutic history and severity of the keloid may influence the effect of treatment. In particular, keloids located on the ear, shoulder, extremities, larger keloids, keloids with extensive therapeutic history and low baseline Vancouver Scar Scale score would potentially be more likely to develop recalcitrance. However, this evidence is limited by limitations in the number and quality of available studies. Chapter 5 shows the results of a double-blind, randomized and controlled study in patients with severe keloid. In this study, patients were treated three times with intralesional bleomycin administered with an EPI in half of the keloidal lesion, and with physiological saline in the other half of the lesion. In this study, objective outcome measures such as volume (measured with a 3D camera) and blood flow (measured with a Laser Speckle Contrast Imaging technique), as well as subjective outcome measures such
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