Dr Yaron Shoham¹, RP Narayan², Torsten Hannmann³, Raphael Staubach³, Stan Monstrey⁴, Henk Hoeksema⁴, Ruzsena Bene⁵, Mohan Kakula⁶, Yvonne Wilson⁷, Giavonni Lewis⁸, Jha Manoj⁹, Shawn Larson¹⁰, Serhii Tatsyuk¹¹, Oleksiy Kravtsov¹², Elena Hanganu¹³, Gheorghe Horea Gozar¹⁴, Guga Kashibadze¹⁵, Tam Pham¹⁶, Tamas Decsi¹⁷, Robert Sheridan¹⁸, Paul Glat¹⁹, Adam Singer²⁰, Frank Sander²¹, Bernd Hartmann²¹, Yehuda Ullman²²

¹Soroka Medical Center, Beer Sheba, Israel, ²ESIC Medical College and Hospital, Faridabad, India, ³Klinikum Stuttgart, Stuttgart, Germany, ⁴Gent University Hospital, Gent, Belgium, ⁵Bethesda Hospital, Budapest, Hungary, ⁶KR Hospital, Mysore, India, ⁷Birmingham’s Children’s Hospital, Birmingham, UK, ⁸University of Utah Burn Center, Salt Lake City, USA, ⁹ABVIMS and Dr. RML Hospital, New Delhi, India, ¹⁰University of Florida, Gainesville, USA, ¹¹Odessa Regional Clinical Medical Center, Odessa, Ukraine, ¹²Zaitsev V.T. Institute of General and Urgent Surgery , Kharkiv, Ukraine, ¹³Spitalul Clinic de Urgenta, Iasi, Romania, ¹⁴Spitalul Clinic de Urgenta, Tg-Mures, Romania, ¹⁵S. Khechinashvili University Hospital, Tbilisi, Georgia, ¹⁶Harborview Medical Center, Seattle, USA, ¹⁷University of Pecs, Pecs, Hungary, ¹⁸Shriner’s Children’s Hospital, Boston, USA, ¹⁹St Christopher’s Hospital for Children, Philadelphia, USA, ²⁰Stony Brook University, Stony Brook, USA, ²¹Unfallkrankenhaus Berlin, Berlin, Germany, ²²Rambam Medical Center, Haifa, Israel

Abstract:

NexoBrid® (NXB) enzymatic debridement is approved for use in adults in several regions worldwide. Clinical trial experience and off label reports point to safety and efficacy in children as well. The objective was to further assess the safety and efficacy of NXB in children.

145 children ≤18 years old suffering from deep burns between 1-30% TBSA were enrolled in a multicenter RCT. 72 children were randomized to debridement with NXB and 73 to standard of care (SOC) debridement. 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. This report includes acute stage and 1 year follow-up results.

Baseline characteristics were similar. Median age was 3.4 years for NXB and 3.9 years for SOC . TBSA was 7.0±4.9% for NXB and 6.2±4.8% for SOC. The study met all primary endpoints: Median time to complete debridement was 1 day for NXB and 6 days for SOC (p<0.001), percent wound area excised 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±409ml for SOC (NS), a 25.9% incidence of autografting in DPT wounds for NXB and 37.7% for SOC (p=0.054), 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 non-inferior time to complete wound closure (median 32 days for NXB, 34 days for SOC) and safety profile was consistent with the safety in adults.

NXB was shown to be a safe and effective debridement agent in pediatric burns.

Biography:

Dr. Shoham is a plastic and reconstructive surgeon currently serving as the director of the Burns Unit at the Soroka Medical Center in Israel, and is the current chairman of the Israeli Burn Association.