Dr Yaron Shoham¹, Prof. Lior Rosenberg^1,2

¹Soroka University Medical Center, Beer Sheba, Israel, ²MediWound Ltd, Yavne, Israel

Abstract:

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.

Biography:

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.