ABSTRACT
INTRODUCTION: Set-up skin markings are performed, in several centers, for radiotherapy (RT) treatments. This study aimed to compare two permanent methods: lancets and an electric marking pen, the Comfort Marker 2.0® (CM). METHODS: This was a prospective, unicentric, randomized study. Patients aged 18 years or older referred to our department to receive RT were recruited. Patients were randomly assigned, in a 1:1 ratio, to receive set-up markings using lancets or CM. The markings arrangement followed our departmental protocols. The coprimary endpoints were patients' comfort and effectiveness. Secondary endpoints included radiation therapists (RTTs) satisfaction and cosmesis. RESULTS: Between October 2021 and January 2022, 100 patients were enrolled (50 received lancets and 50 CM) and assessed for the comfort and satisfaction outcomes. CM was significantly less painful than the lancets, with 44% and 16% of the patients, respectively, considering the tattooing process painless (RR = 2.75; 95% IC: 1.36 - 5.58). On the RTT-reported satisfaction, CM had significantly easier processes than lancets (98.0% vs. 78.0%, respectively; RR = 1.26; 95% CI: 1.08 - 1.46). For effectiveness and cosmesis assessment, 98 patients were analyzed (48 received lancets and 50 CM). Patients receiving CM had a significantly higher proportion of markings graded as good and excellent compared to those receiving lancets (98.0% and 50.0%, respectively, had ≥75% of the tattoos assessed as good/excellent, RR = 1.96; 95% CI: 1.47 - 2.61). On the cosmetic evaluation, patients receiving CM had significantly better cosmetic markings, with a median score of 4.4 (vs. 3.5 for lancets, p <0.001). CONCLUSION: The trial results demonstrated that tattooing with the CM is significantly less painful, more effective, easier to apply, and cosmetically superior to tattooing with lancets. IMPLICATIONS FOR PRACTICE: Tattooing with CM allows for better results regarding pain, quality, ease and cosmesis.
