Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns.

OBJECTIVES

This study evaluated the safety and efficacy of an enzymatic bromelain-based debridement (BBD) agent (NexoBrid®) in children with deep thermal burns.

METHODS

We conducted a multicenter, open-label, parallel design, randomized controlled trial at 36 burn centers in Europe, US, Israel and India. Main eligibility criteria included children 0-18 years old, suffering from deep thermal burns covering 1-30 % of their total body surface area. Patients were randomized to either BBD or standard of care (SOC) eschar removal methods. Primary endpoints included time to complete eschar removal (superiority), percentage of wound area surgically excised (superiority) and blinded 12 months follow-up assessment of cosmesis and function using the Modified Vancouver Scar Scale (MVSS, non-inferiority).

RESULTS

One hundred and forty-five children were enrolled between 2015 and 2020 (last patient completed 12-month follow-up on April 2021); 72 were randomized to BBD and 73 to SOC. All three primary endpoints of the study were met. The median time to complete eschar removal was significantly lower in the BBD arm (1 vs. 6 days, P < 0.001). The mean [SD] percentage of wound area surgically excised was also significantly lower in the BBD arm (1.5 % [12.1 %] vs. 48.1 % [46.6 %], P < 0.001). Mean [SD] 12-month MVSS scores were 3.8 [2.9] and 4.9 [3.3] in the BBD and SOC arms, respectively (non-inferiority demonstrated at P < 0.001). The incidence of adverse events was similar between the groups, and there were no significant safety issues or deaths during the trial.

CONCLUSIONS

BBD was demonstrated to be safe and effective in children. Its use lead to a shorter time to complete eschar removal, a reduction in excisional surgery and non-inferior cosmesis and function results as compared to SOC eschar removal methods.