Objectives: NexoBrid® (NXB) enzymatic debridement of deep burns is approved for use in adults in several regions worldwide. Clinical trial experience and off label reports point to NXB safety and efficacy in children as well. The objective of this study was to further assess the safety and efficacy of NXB in children, in efforts to support regulatory approval for its use in children.
Methods: 145 children ≤18 years old suffering from deep thermal burns between 1-30% TBSA were enrolled in a multicenter, multinational, open label, randomized, controlled phase III study. 72 children were randomized to debridement with NXB and 73 children to standard of care (SOC) surgical and/or non-surgical debridement methods, at the investigators' discretion. Patients who did not achieve complete debridement after NXB application were rescued with SOC debridement methods. Wound care after achieving complete debridement was according to routine methods, at the investigators' discretion. Patients then continued follow up for >3 years. This abstract reports the acute stage results of the study and the first year of follow-up.
Results: Baseline characteristics were similar between the arms. Median age was 3.4 years in the NXB arm and 3.9 years in the SOC arm. Average burn area was 7.0±4.9 %TBSA in the NXB arm and 6.2±4.8 %TBSA in the SOC arm. The study met all 3 primary endpoints: Median time to complete debridement was 1 day for NXB and 6 days for SOC (p<0.001), the percent wound area excised in order to complete debridement was 1.5% for NXB and 48% for SOC (p<0.0001), and MVSS scores at 12 months were 3.83 for NXB and 4.86 for SOC (non-inferiority endpoint). Secondary endpoints demonstrated 8.3% incidence of surgical excision to complete debridement for NXB and 64.4% for SOC (p<0.0001), mean debridement associated blood loss of 32±284ml for NXB and 202±409 for SOC (NS), a 25.9% incidence of autografting in DPT wounds for NXB and 37.7% for SOC (p=0.054), and a mean percent area of DPT wound autografting of 15.9±38.6 for NXB and 22.8±43.7 for SOC (NS). Safety endpoints demonstrated a non-inferior time to complete wound closure (median 32 days for NXB, 34 days for SOC) and the safety profile was consistent with the safety in adults.
Conclusions: NXB was shown to be a safe and effective debridement agent in pediatric burns.
*Funded by MediWound Ltd. and by US Federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA, under Contract No. HHSO100201500035C

**Objectives**: NexoBrid® (NXB) enzymatic debridement of deep burns is approved for use in adults in several regions worldwide. Clinical trial experience and off label reports point to NXB safety and efficacy in children as well. The objective of this study was to further assess the safety and efficacy of NXB in children, in efforts to support regulatory approval for its use in children.
**Methods**: 145 children ≤18 years old suffering from deep thermal burns between 1-30% TBSA were enrolled in a multicenter, multinational, open label, randomized, controlled phase III study. 72 children were randomized to debridement with NXB and 73 children to standard of care (SOC) surgical and/or non-surgical debridement methods, at the investigators' discretion. Patients who did not achieve complete debridement after NXB application were rescued with SOC debridement methods. Wound care after achieving complete debridement was according to routine methods, at the investigators' discretion. Patients then continued follow up for >3 years. This abstract reports the acute stage results of the study and the first year of follow-up.
**Results**: Baseline characteristics were similar between the arms. Median age was 3.4 years in the NXB arm and 3.9 years in the SOC arm. Average burn area was 7.0±4.9 %TBSA in the NXB arm and 6.2±4.8 %TBSA in the SOC arm. The study met all 3 primary endpoints: Median time to complete debridement was 1 day for NXB and 6 days for SOC (p<0.001), the percent wound area excised in order to complete debridement was 1.5% for NXB and 48% for SOC (p<0.0001), and MVSS scores at 12 months were 3.83 for NXB and 4.86 for SOC (non-inferiority endpoint). Secondary endpoints demonstrated 8.3% incidence of surgical excision to complete debridement for NXB and 64.4% for SOC (p<0.0001), mean debridement associated blood loss of 32±284ml for NXB and 202±409 for SOC (NS), a 25.9% incidence of autografting in DPT wounds for NXB and 37.7% for SOC (p=0.054), and a mean percent area of DPT wound autografting of 15.9±38.6 for NXB and 22.8±43.7 for SOC (NS). Safety endpoints demonstrated a non-inferior time to complete wound closure (median 32 days for NXB, 34 days for SOC) and the safety profile was consistent with the safety in adults.
**Conclusions**: NXB was shown to be a safe and effective debridement agent in pediatric burns.
*Funded by MediWound Ltd. and by US Federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA, under Contract No. HHSO100201500035C

P.040 Safety and efficacy of NexoBrid enzymatic burn debridement in children: Results of the CIDS multicenter RCT

Dear friends and colleagues,

We will be pleased to welcome you in Turin (Italy) for the 19th European Burns Association´s Congress in 2022. Italy is honored to hold the meeting of the European Burns Association for the second time, after Verona in 1995. Turin is easily reachable from everywhere in Europe, either travelling by car, train or choosing flight connections. During the meeting, held in the renewed industrial center of the main Italian historical automotive factory (i.e. Lingotto-FIAT), we will meet international burn specialists, focusing on standards of care, progresses in burn treatment, strategies to face disaster situations, with a special attention to education of younger colleagues. However, in your spare time, you might enjoy the sweet days of Italian late summer, simply wandering in the green parks and gardens along the two rivers which cross the city, or you might decide to discover the numerous art galleries, churches, palaces, libraries, walking across elegant squares and large boulevards, passing through centuries of art and history; finally, you may choose to immerse yourself in some of the most exciting museum experiences, such as the Cinema Museum and the Turin’s Egyptian museum.

Looking forward to seeing you all in Turin for the 19th European Association´s Congress in 2022!
Maurizio Stella, Congress President, Turin Burn Centre