Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision.

Abstract:

BACKGROUND:Previous studies of recombinant human thrombin (rThrombin) enrolled adult and adolescent patients. This phase 4, open-label, single-group study was conducted in pediatric patients undergoing synchronous burn wound excision and skin grafting to provide information regarding the safety and immunogenicity of rThrombin (primary and secondary endpoints) in this population. METHODS:Topical rThrombin was applied as a hemostatic aid during a surgical procedure (day 1). Adverse events and clinical laboratory abnormalities were recorded during the study. Immunogenicity samples were collected on days 1 and 29 (study end). Study results were summarized with descriptive statistics. RESULTS:Thirty patients enrolled and 28 completed the study. Mean age was 6.9 years (range, 0.9-17.8 years); 40.0% of patients were girls. Flame and scald were the most common burn types (33.3% each, n = 10/30). Mean graft size was 3.6% total body surface area. Procedural pain (50.0% patients), pruritus (43.3%), and anemia (30.0%) were the most commonly reported adverse events. All adverse events and clinical laboratory abnormalities were considered unrelated to treatment. No patients developed anti-rThrombin product antibodies at day 29. CONCLUSIONS:In pediatric patients undergoing burn wound excision and skin grafting, rThrombin was well tolerated and did not lead to the formation of anti-rThrombin product antibodies.

journal_name

J Pediatr Surg

authors

Foster KN,Mullins RF,Greenhalgh DG,Gamelli RL,Glat P,Lentz CW,Kahn SA,Brandigi C,Fredlund P,Alexander WA

doi

10.1016/j.jpedsurg.2011.05.022

subject

Has Abstract

pub_date

2011-10-01 00:00:00

pages

1992-9

issue

10

eissn

0022-3468

issn

1531-5037

pii

S0022-3468(11)00506-9

journal_volume

46

pub_type

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