Rapid enzymatic burn debridement: A review of the paediatric clinical trial experience.
NexoBrid
burn debridement
enzymatic debridement
escharotomy
paediatric burns
Journal
International wound journal
ISSN: 1742-481X
Titre abrégé: Int Wound J
Pays: England
ID NLM: 101230907
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
25
03
2020
revised:
20
04
2020
accepted:
05
05
2020
pubmed:
24
5
2020
medline:
19
8
2021
entrez:
24
5
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 32445271
doi: 10.1111/iwj.13405
pmc: PMC7949204
doi:
Substances chimiques
Bromelains
9001-00-7
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1337-1345Subventions
Organisme : Mediwound Ltd.
Informations de copyright
© 2020 Medicalhelplines.com Inc and John Wiley & Sons Ltd.
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