A novel subvacuum dressing to treat superficial second-degree burn wounds in children: a prospective, randomized, non-inferiority, multicenter study

• Novel subvacuum dressing enhances superficial 2nd-degree burn healing in children. • The two dressings had no significant differences in wound healing. • The novel subvacuum dressing demonstrates excellent safety. Novel subvacuum dressing enhances superficial 2nd-degree burn healing in children. The two dressings had no significant differences in wound healing. The novel subvacuum dressing demonstrates excellent safety. Superficial second-degree burns pose major clinical challenges, including extended healing time duration, infection risk, and patient discomfort. Although advanced synthetic dressings such as self-adhesive silicone foam (Mepilex®XT) improve outcomes, novel interventions require evaluation. This study compares efficacy and safety between a novel subvacuum dressing and Mepilex®XT in managing superficial second-degree burns in children. The aim of this study was to investigate whether the novel subvacuum dressing for superficial second-degree burns is non-inferior to Mepilex®XT. This prospective, randomized, controlled multicenter non-inferiority trial enrolled 82 participants aged 2-14 years with superficial second-degree burns. Patients were randomly assigned to the experimental (novel subvacuum dressing) or control (Mepilex®XT) groups. A total of 78 participants completed the study, comprising 41 in the experimental group and 37 in the control group. The primary outcome was time to complete wound closure via standardized assessment. Secondary outcomes included infection rates and adverse reactions. Baseline comparability was assessed for patient demographics, burn size, and anatomical location. No significant intergroup differences were observed in baseline characteristics (all P > 0.05). Time to complete wound closure was comparable between groups (P > 0.05). Safety profiles were similar, with no significant differences in adverse event frequency or severity (P > 0.05). Experimental dressing and standard care results demonstrated no significant differences across all metrics. The novel subvacuum dressing demonstrated comparable efficacy and safety to Mepilex®XT, proving beneficial in promoting healing of superficial second-degree burns in pediatric patients.