Rapid enzymatic burn debridement: A review of the paediatric clinical trial experience

Abstract

NexoBrid (NXB) has been proven to be an effective selective enzymatic debridement agent in adults. This manuscript presents the combined clinical trial experience with NXB in children. Hundred and ten children aged 0.5 to 18 years suffering from deep thermal burns of up to 67% total body surface area were treated with NXB in three clinical trials. Seventy‐seven children were treated with NXB in a phase I/II study, where 92.7% of the areas treated achieved complete eschar removal within 0.9 days from admission. Thirty‐three children (17 NXB, 16 standard of care [SOC]) participated in a phase III randomized controlled trial. All wounds treated with NXB achieved complete eschar removal. Time to complete eschar removal (from informed consent) was 0.9 days for NXB vs 6.5 days for SOC (P < .001). The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001). Seventeen of these children participated in a phase III‐b follow‐up study (9 NXB and 8 SOC). The average long‐term modified Vancouver Scar Scale scores were 3.4 for NXB‐treated wounds vs 4.4 for SOC‐treated wounds (NS). There were no significant treatment‐related adverse events. Additional studies are needed to strengthen these results.

Preliminary Single-Center Experience of Bromelain-Based Eschar Removal in Children with Mixed Deep Dermal and Full Thickness Burns

“…The pretreatment risk stratification, adequate monitoring and hemodynamic support are needed when treating patients on more than 15% TBSA [ 15 , 16 , 17 ]. The literature lacks studies reporting the use of enzymatic debridement in children, with the exception of one manuscript presenting the combined experience in the use of Nexobrid ® in pediatric burns throughout three clinical trials, and the study that explores the different possibilities for pain management during enzymatic debridement in pediatric and adult burn patients [ 18 , 19 ].…”

“…Autografting in deep partial thickness wounds was performed in 21.7% of the wounds debrided enzymatically vs. 31.8% of the wounds treated surgically ( p = 0.44). The average long-term modified Vancouver Scar Scale scores were 3.4 for 18 wounds in 8 children treated with Nexobrid ® versus 4.4 for 19 wounds in 9 children debrided using surgical methods [ 18 ]. Another study on adults showed a significant difference in the scar surface appearance (modified Yeong scale), with an average score of 2.5 in the study group, in comparison with 3.2 in SoC patients [ 27 ].…”

Role, Development, and Value of Enzymatic Debridement as Integral Component in Initial Treatment of Burn Injuries Exemplified by NexoBrid®

“…Consenting exceedance of market approval comprised application in paediatric patients [111], utilization for up to 30% TBSA [112], waiver of pre-soaking under certain conditions, applicability for prevention of peripheral BICS, prolonged enzyme application for up to 18 h for improved results, or possible but reluctant retreatment with ED [64,65]. However, explicit surpassing of official recommendations has clearly been pointed out as off-label use.…”

Advances in the treatment of burned children

“…Regarding potential side-effects, such as bed bleeding or allergies, they have not been documented in pediatric patients yet, since the clinical trial is still in progress. However, anaphylactic reactions have been noted in patients allergic to pineapple (15) .…”