Recombinant thrombin: Safety and immunogenicity in burn wound excision and grafting

David G Greenhalgh, Richard L. Gamelli, Jay Collins, Rajiv Sood, David W. Mozingo, Todd E. Gray, W. Allan Alexander

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

This study evaluated the safety, immunogenicity, and hemostatic effect of recombinant human Thrombin (rThrombin), in patients undergoing skin grafting for burns. This was a phase 2 multiple site, single-arm, open-label study in patients receiving partial- or full-thickness autologous grafts. rThrombin was applied using a spray applicator to newly excised wounds of 1 to 4% body surface area at 5 minutes intervals for up to 20 minutes, after point source bleeding was stopped. Adverse events, skin graft survival, and formation of anti-rThrombin antibodies were measured at baseline and Day 29. There were no deaths or study drug discontinuations. Adverse events occurred in 63 of 72 patients (88%), and were typical of sequelae of skin grafting. Hemostasis was achieved within 20 minutes after application of rThrombin in 65 of 71 patients (91.5%). Skin graft failure occurred in 4 patients (6%). At the day 29 evaluation, for those patients who returned, 88.9% had '90% graft survival. One patient (1 of 70, 1.4%) had specific, low titer antibodies to rThrombin at baseline, but no increase in titer posttreatment; a second patient (1 of 62, 1.6%), developed antibodies to rThrombin at day 29. None of the antibodies neutralized native human thrombin. In excised burn wounds, hemostasis at 20 minutes was achieved in 91.5% of patients and skin graft survival was excellent. There was a low rate of antibodies to rThrombin at baseline (1.4%) and a low rate of anti-rThrombin antibody formation at day 29 (1.6%). rThrombin was well tolerated when administered with a pump spray.

Original languageEnglish (US)
Pages (from-to)371-379
Number of pages9
JournalJournal of Burn Care and Research
Volume30
Issue number3
DOIs
StatePublished - May 2009

Fingerprint

Thrombin
Safety
Wounds and Injuries
Graft Survival
Antibodies
Skin Transplantation
Hemostasis
Skin
Transplants
recombinant human thrombin
Body Surface Area
Hemostatics
Burns
Population Groups
Antibody Formation
Hemorrhage
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Emergency Medicine
  • Rehabilitation
  • Surgery

Cite this

Recombinant thrombin : Safety and immunogenicity in burn wound excision and grafting. / Greenhalgh, David G; Gamelli, Richard L.; Collins, Jay; Sood, Rajiv; Mozingo, David W.; Gray, Todd E.; Alexander, W. Allan.

In: Journal of Burn Care and Research, Vol. 30, No. 3, 05.2009, p. 371-379.

Research output: Contribution to journalArticle

Greenhalgh, David G ; Gamelli, Richard L. ; Collins, Jay ; Sood, Rajiv ; Mozingo, David W. ; Gray, Todd E. ; Alexander, W. Allan. / Recombinant thrombin : Safety and immunogenicity in burn wound excision and grafting. In: Journal of Burn Care and Research. 2009 ; Vol. 30, No. 3. pp. 371-379.
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abstract = "This study evaluated the safety, immunogenicity, and hemostatic effect of recombinant human Thrombin (rThrombin), in patients undergoing skin grafting for burns. This was a phase 2 multiple site, single-arm, open-label study in patients receiving partial- or full-thickness autologous grafts. rThrombin was applied using a spray applicator to newly excised wounds of 1 to 4{\%} body surface area at 5 minutes intervals for up to 20 minutes, after point source bleeding was stopped. Adverse events, skin graft survival, and formation of anti-rThrombin antibodies were measured at baseline and Day 29. There were no deaths or study drug discontinuations. Adverse events occurred in 63 of 72 patients (88{\%}), and were typical of sequelae of skin grafting. Hemostasis was achieved within 20 minutes after application of rThrombin in 65 of 71 patients (91.5{\%}). Skin graft failure occurred in 4 patients (6{\%}). At the day 29 evaluation, for those patients who returned, 88.9{\%} had '90{\%} graft survival. One patient (1 of 70, 1.4{\%}) had specific, low titer antibodies to rThrombin at baseline, but no increase in titer posttreatment; a second patient (1 of 62, 1.6{\%}), developed antibodies to rThrombin at day 29. None of the antibodies neutralized native human thrombin. In excised burn wounds, hemostasis at 20 minutes was achieved in 91.5{\%} of patients and skin graft survival was excellent. There was a low rate of antibodies to rThrombin at baseline (1.4{\%}) and a low rate of anti-rThrombin antibody formation at day 29 (1.6{\%}). rThrombin was well tolerated when administered with a pump spray.",
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