Recombinant Thrombin: Safety and Immunogenicity in Burn Wound Excision and Grafting

@article{Greenhalgh2009RecombinantTS,
  title={Recombinant Thrombin: Safety and Immunogenicity in Burn Wound Excision and Grafting},
  author={David G. Greenhalgh and Richard L. Gamelli and Jay N. Collins and Rajiv Sood and David W. Mozingo and T. E. Gray and W. Allan Alexander},
  journal={Journal of Burn Care \& Research},
  year={2009},
  volume={30},
  pages={371-379}
}
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… Expand
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References

SHOWING 1-10 OF 37 REFERENCES
Efficacy and Safety of a Fibrin Sealant for Adherence of Autologous Skin Grafts to Burn Wounds: Results of a Phase 3 Clinical Study
TLDR
It is demonstrated that FS 4IU VH S/D is safe and effective for attachment of skin grafts, with outcomes at least as good as or better than staple fixation. Expand
Multicenter trial to evaluate the safety and potential efficacy of pooled human fibrin sealant for the treatment of burn wounds.
TLDR
Although investigators felt that fibrin sealant (human) improved donor site hemostasis, differences in hemoglobin measurements of blood-soaked dressings failed to reach significance and its role in scar maturation also needs to be investigated. Expand
Comparison of Fibrin Sealant and Staples for Attaching Split-Thickness Autologous Sheet Grafts in Patients With Deep Partial- or Full-Thickness Burn Wounds: A Phase 1/2 Clinical Study
  • N. Gibran, A. Luterman, +8 authors L. Riina
  • Medicine
  • Journal of burn care & research : official publication of the American Burn Association
  • 2007
TLDR
It is indicated that fibrin sealant containing 4 IU/ml thrombin (FS 4IU) is safe and effective for fixation of skin grafts, with outcomes similar to or better than staple fixation. Expand
Effect of topical and subcutaneous epinephrine in combination with topical thrombin in blood loss during immediate near-total burn wound excision in pediatric burned patients.
TLDR
The routine use of local epinephrine during total wound excision in combination with topical thrombin in pediatric patients operated within 24 h after the admission may not be necessary. Expand
The role of topical thrombin in skin grafting.
TLDR
A prospective study to evaluate the efficacy of thrombin as a hemostatic agent in burn patients showed a 43.5% reduction in bleeding on the Thrombin-treated sites compared with the control sites, and there was no adverse effect on the rate of wound healing from theThrombin. Expand
A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis.
TLDR
Results of this trial suggest that rhThrombin has comparable efficacy, a similar safety profile, and is considerably less immunogenic than bovine thrombin when used for surgical hemostasis. Expand
Minimizing blood loss in burn surgery.
TLDR
The application of a strict and comprehensive intraoperative blood conservation strategy during burn excision and grafting resulted in a profound reduction in blood loss and transfusion requirements, without compromising wound outcome. Expand
A prospective study of blood loss with excisional therapy in pediatric burn patients.
TLDR
Assessment of losses by age and depth of wound, patient age, and anatomic site showed no differences between these groups, and Tourniquets lowered intraoperative losses but had no effect on overall losses. Expand
Topical Treatment of Pediatric Patients with Burns
TLDR
Topical antimicrobial agents have been shown to decrease wound-related infections and morbidity in burn wounds when used appropriately and the goal of topical antimicrobial therapy is to control microbial colonization, thus preventing development of invasive infections. Expand
The use of sheet autografts to cover extensive burns in patients.
TLDR
Sheet autografting should be considered for more important cosmetic and functional areas, such as the face and hands, for massive burns, and for covering moderately sized burns. Expand
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