Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision.
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.
Arizona Burn Center at Maricopa Medical Center, Phoenix, AZ, USA.
Kevin N
KN
Foster
R Fred
RF
Mullins
David G
DG
Greenhalgh
Richard L
RL
Gamelli
Paul
P
Glat
Christopher W
CW
Lentz
Steven A
SA
Kahn
Claus
C
Brandigi
Paul
P
Fredlund
W Allan
WA
Alexander
D000287:Administration, Topical; D000293:Adolescent; D000740:Anemia / Q000453:epidemiology; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002056:Burns / Q000601:surgery*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay; D004837:Epinephrine / Q000627:therapeutic use; D005260:Female; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007518:Isoantibodies / Q000096:biosynthesis / Q000097:blood*; D008297:Male; D010146:Pain / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D011537:Pruritus / Q000453:epidemiology; D011994:Recombinant Proteins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D016038:Skin Transplantation; D013917:Thrombin / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*
D006490:Hemostatics; D007518:Isoantibodies; D011994:Recombinant Proteins; D013917:Thrombin; C513462:recombinant human thrombin; D004837:Epinephrine