Background <p>Burn injuries remain a major health challenge, particularly in developing countries, where insufficient clinical training has led to significant competency gaps among medical students and young physicians. Despite the demonstrated potential of serious games to enhance clinical skills through interactive simulation, little research has explored their impact on burn management education. This study was conducted to design and evaluate an educational serious game aimed at improving the clinical competence of medical students in managing diverse and complex burn cases.</p> Methods <p>This parallel-group randomized clinical trial, conducted at the Burn Department of Imam Reza Hospital in Mashhad, involved 70 medical students. Inclusion criteria were medical students from Mashhad University of Medical Sciences, about to begin burn clinical rotations, with no prior burn management experience. Participants were randomly assigned to an intervention group, which received standard training plus the serious game, or to a control group that received standard training only. Before and after their training period, students participated in clinical competency assessments that utilized the Mini-Clinical Evaluation Exercise (Mini-CEX).</p> Results <p>A total of 70 students participated in the study, with 35 allocated to the intervention group and 35 to the control group. No statistically significant differences were observed between the groups in terms of demographic characteristics (<i>P</i> &gt; 0.05). Post-intervention evaluations demonstrated statistically significant improvements in all seven skills in both groups (<i>P</i> &lt; 0.001). Furthermore, the intervention group exhibited significantly greater increases in both teacher and student satisfaction compared to the control group (<i>P</i> &lt; 0.001).</p> Conclusions <p>The incorporation of serious games into medical education represents a transformative strategy that significantly enhances learning outcomes. These educational tools create engaging and interactive environments that not only reinforce students’ clinical skills but also prepare them with the essential competencies needed to tackle real-world challenges effectively. The ongoing exploration of innovative educational strategies is vital for further improving the quality of medical education.</p> Trial registration <p>This RCT was registered in the Iran Registry of Clinical Trials (IRCTID: IRCT20171123037599N3, <a href="https://irct.behdasht.gov.ir/trial/70898">https://irct.behdasht.gov.ir/trial/70898</a>), Registration date: 10/08/2023.</p>