Dr Yaron Shoham1, Prof. Lior Rosenberg1,2
1Soroka University Medical Center, Beer Sheba, Israel, 2MediWound Ltd, Yavne, Israel
Introduction: Bromelain based enzymatic debridement of deep burns with NexoBrid (NXB) is approved for use in several regions around the world. As part of regulatory requirements in the US and Europe a second phase 3 multicenter RCT was conducted.
Methods: 175 adults suffering from deep burns were included in a multinational, multicenter, randomized, controlled, assessor blinded trial (DETECT). Patients were randomized to 3 treatment arms – NXB, Standard of Care (SOC), or Gel vehicle (placebo) in a 3:3:1 ratio (75 NXB, 75 SOC, 25 Gel).
Results: Baseline characteristics were comparable across study arms. The incidence of complete eschar removal (primary endpoint) was significantly higher for NXB vs Gel patients (93.3% vs 4%, p<0.0001). The incidence of surgical eschar removal was significantly lower for NXB vs SOC patients (4% vs 72%, p<0.0001). Time to complete eschar removal was significantly shorter for NXB vs SOC patients (median 1 day vs 3.8 days, p<0.0001). Eschar removal associated blood loss was significantly lower for NXB vs SOC patients (14ml vs 815ml, p<0.0001). Time to complete wound closure was similar for NXB and SOC patients (median 27 and 28 days). One year follow-up MVSS scores were significantly lower (p<0.01) in the NXB group (3.70±2.10) as compared to both SOC (5.08±3.11) and Gel groups (5.63±2.99). NXB patients’ safety profile was good, consistent with previous trials.
Conclusions: These results further demonstrate the safety and efficacy of NXB which are in line with previous trials results. Additionally, the NXB group 12-month follow up MVSS scores were significantly superior.
Dr. Shoham is the director of the Burn Unit at the Soroka University Medical Center in Israel and the current chairman of the Israeli Burn Association.