350 Efficacy of Bromelain-based Enzymatic Eschar Removal: Combined Clinical Trial Results of 546 Patients Academic Article uri icon

abstract

  • Introduction Bromelain based enzymatic debridement (BBED) of deep thermal burns was approved for use in the European Union in 2012 and since then >3000 patients have been treated there. BBED is currently an investigational product in the US in a phase III multicenter randomized controlled trial. This trial is the 8th clinical trial performed with BBED and its primary endpoint is the efficacy of enzymatic eschar removal in deep thermal burns within a 4 hour topical treatment. The aim of this report is to examine the combined enzymatic eschar removal efficacy results from the clinical trials completed to date. Methods Seven clinical trials with BBED were completed before 2017. Three trials included a single treatment arm (BBED), two trials included randomization of patients into 2 arms - BBED or standard of care (SOC, surgical/non-surgical), and two trials included randomization of patients into 3 arms - BBED, SOC or a gel vehicle as a placebo. Accordingly, burn wounds were treated with either a 4 hour BBED/placebo application, or according to the investigators’ discretion (SOC). Assessments of eschar removal efficacy were performed by the investigators. Complete eschar removal was initially defined as >90% eschar removal and was recently updated to >95% eschar removal in accordance with the ABA consensus statements published in 2013. Only patients with a recorded eschar removal assessment were included in this analysis. Results A total of 546 patients were included in this analysis, of which 375 were treated with BBED, 127 with SOC, and 44 with a gel placebo. The incidences of complete eschar removal were 94.2% for the BBED patients, 93.9% for the SOC patients and 0 for the gel placebo patients. The time to complete eschar removal from injury (available in 297 patients that participated in 3 of the trials -181 treated with BBED, 116 with SOC) was 1.96 days for BBED patients and 10.39 days for SOC patients. None of the BBED treated patients had any serious adverse events that were considered by the investigators to be related to BBED, except for a single case of graft failure. Conclusions The compiled clinical data demonstrate the safety, efficacy and rapid action of BBED, which was shown to be as safe and efficient as SOC, but lead to a much earlier completion of eschar removal. BBED patients completed eschar removal within 2 days of injury, well within the definition of early excision whose benefits are well known, and much earlier than the patients randomized to SOC. It is probable that BBED time to complete eschar removal would have been even shorter had these patients not been treated in a clinical trial, as trial enrollment procedures before BBED application can be time consuming. Applicability of Research to Practice BBED of deep thermal burns leads to an early eschar removal, while being as safe and effective as SOC.

publication date

  • April 9, 2018