380 Bromelain Based Rapid Enzymatic Debridement - Comparing Pediatric and Adult Clinical Trial Results

Abstract

Bromelain Based Debridement (BBD) of deep burns is approved for use in adults in Europe, Argentina, Russia, South Korea and Israel. In the US it is an investigational product in 2 multicenter RCTs (DETECT - adults, CIDS - children). The aim of this study is to compare the results of the pediatric vs adult populations in former BBD trials. Mixed populations of children and adults were enrolled in 3 of 7 former BBD trials - a phase II trial, phase III trial, and a phase IIIb long term follow up trial. Phase II trial - 77 children and 77 adults suffering from deep burns were treated with BBD in a prospective, single arm, single-center trial. Data was retrospectively retrieved and analyzed for safety and efficacy of eschar removal, and need for autografting. Phase III trial - 33 children and 148 adults suffering from deep burns were treated with BBD or SOC as part of a multi-center randomized controlled trial. Seventeen children and 83 adults were treated with BBD. Sixteen children and 65 adults were treated according to the investigators’ standard of care (SOC). End points included safety, efficacy of and time to complete eschar removal, and need for surgical excision and grafting.. Phase IIIb trial - 17 children and 72 adults were available for a 2-4 year post injury long term follow-up. End points included scar evaluation by blinded assessors, need for scar modulation or reconstruction, and quality of life (QoL). Phase II trial: Pediatric results were slightly better vs adults; incidence of complete eschar removal (92% vs 91%), need for autografting after BBD (34% vs 42%), graft take (94% vs 93%), days to complete wound closure (21.4 vs 22.2). Phase III trial: In general, most of the results of BBD treated patients were significantly better than SOC patients. This BBD/SOC effect was even more pronounced in children vs adults in most parameters; incidence of complete eschar removal (100%/94% vs 88%/89%), a 9.1 vs 3.6 times reduction in the area that underwent surgical eschar removal (8%/73% vs 14%/51%), a 4.2 vs 2.2 times reduction in DPT areas that underwent autografting (6%/25% vs 9%/20%), a 2.5 vs 1.8 times reduction in blood loss, and less days to complete wound closure (30/32 vs 38/28). Phase IIIb trial: Long term MVSS scores were also in line with the more pronounced BBD/SOC effect in children vs adults (3.39/4.37 vs 3.07/3.07). There was a significant reduction in the presence of donor site scars in the overall population (40% BBD vs 68% SOC) and lower scar modulation (27.8% vs 34.3%) and reconstruction rates (3.7% vs 8.6%). QoL rates were similar. The results of children treated by BBD appear to be even better than in adults. The ongoing DETECT and CIDS trials should shed more light on this issue. BBD may be a powerful debridement agent in children.