Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision
| Autor: | Steven Kahn, W. Allan Alexander, Claus Brandigi, Richard L. Gamelli, Christopher W. Lentz, Paul M. Glat, Paul Fredlund, R. Fred Mullins, Kevin N Foster, David G. Greenhalgh |
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| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Epinephrine Anemia Administration Topical medicine.medical_treatment Population Blood Loss Surgical Pain Enzyme-Linked Immunosorbent Assay Postoperative Hemorrhage Hemostatics Postoperative Complications Pharmacotherapy Isoantibodies Humans Medicine Child Adverse effect education education.field_of_study Hemostatic Techniques business.industry Pruritus Immunogenicity Thrombin Infant Skin Transplantation General Medicine medicine.disease Combined Modality Therapy Recombinant Proteins Surgery Clinical trial Child Preschool Pediatrics Perinatology and Child Health Skin grafting Drug Therapy Combination Female Burns business Total body surface area |
| Zdroj: | Journal of Pediatric Surgery. 46:1992-1999 |
| ISSN: | 0022-3468 |
| DOI: | 10.1016/j.jpedsurg.2011.05.022 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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