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

  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},
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… 

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

Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.

Thrombin use in surgery: an evidence-based review of its clinical use

The history, pharmacology and clinical application of thrombin as a surgical hemostat is discussed, and recently a recombinantThrombin has been developed, and approved for use by the FDA and has the advantage of being minimally antigenic and devoid of the risk of viral transmission.

Recombinant Human Thrombin

Abstract▴ Recombinant human thrombin (rhThrombin) is a serine protease coagulant, manufactured in vitro using recombinant DNA technology, which shares an identical amino acid sequence and similar

Acquired Factor V Deficiency Associated With Exposure to Bovine Thrombin in a Burn Patient

The first case of factor V deficiency and profound coagulopathy in a burn patient after intraoperative exposure to bovine thrombin is documents, and the use of bovines-thrombin-containing products should be avoided in burn patients with prior exposure.

Advancements in Regenerative Strategies Through the Continuum of Burn Care

The aim of this review is to highlight how tissue engineering and regenerative medicine strategies are being used to address the unique challenges of burn wound healing and define the current gaps in care for both partial- and full-thickness burn injuries.

Topical hemostatic therapy in surgery: bridging the knowledge and practice gap.



Efficacy and Safety of a Fibrin Sealant for Adherence of Autologous Skin Grafts to Burn Wounds: Results of a Phase 3 Clinical Study

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.

Multicenter trial to evaluate the safety and potential efficacy of pooled human fibrin sealant for the treatment of burn wounds.

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.

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. GibranA. Luterman L. Riina
  • Medicine
    Journal of burn care & research : official publication of the American Burn Association
  • 2007
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.

The role of topical thrombin in skin grafting.

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.

A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis.

Minimizing blood loss in burn surgery.

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.

A prospective study of blood loss with excisional therapy in pediatric burn patients.

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.

Topical Treatment of Pediatric Patients with Burns

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.

The use of sheet autografts to cover extensive burns in patients.

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.