EHTIC study: Evaluation of a new hemostatic agent based on tissue factor in skin grafting procedures

Autors de IIS La Fe

• María Dolores Pérez Del Caz

  Autor

• Juan Ramón Esteban Vico

  Autor

• María Eloisa Villaverde Domenech

  Autor

• Abel Francisco Llinas Porte

  Autor

Autors aliens a IIS La Fe

• Rojas, Santiago
• Ramon Martinez, Jose
• Brage, Carlos
• Valero, Javier
• Gonzalez Rodriguez, Alba
• Garcia Barreiro, Juan
• Lopez-Suso, Eugenia
• Luis Fernandez-Canamaque, Jose
• Lopez, Ramon
• Murat, Jesus
• EHTIC Study Investigators Grp

Grups d'Investigació

• Dermatología y Regeneración Tisular

  

  Leader

  Rafael Botella Estrada

Abstract

Background: Excessive bleeding is a major concern in scar debridement and grafting procedures. TT-173 is a new topical hemostatic agent based on recombinant human tissue factor that has shown promising results in patients who underwent tooth extraction. EHTIC study sought to evaluate the efficacy and safety of TT-173 to reduce the bleeding in donor sites of skin grafting procedures. Methods: EHTIC study was a phase II, randomized, parallel, double blind, placebo controlled trial. Patients received TT-173 (n=38) or placebo (n=33) sprayed over donor site after graft harvest. Time to hemostasis and incidence of adverse events were recorded. Systemic absorption of the product and its immunogenicity were also measured during the follow up of the subjects. Results: Treatment with TT-173 significantly reduced the bleeding time from 7 to 3min (Log Rank p < 0.0001). Moreover, bleeding stopped within the 10min of evaluation period in all the patients that received TT-173. In contrast, 24.24% of patients from placebo group required additional measures to arrest hemorrhage (Fisher p = 0.0013). Product related adverse events, systemic absorption into blood stream, interferences with the healing of the donor site or immunogenic reaction against TT-173 were not observed. Conclusion: The new hemostatic agent TT-173 has proven efficacious and safe to reduce the bleeding from donor site. This study paves the way for further investigation of the product as topical hemostatic treatment in plastic surgery and other surgical indications. (C) 2017 Elsevier Ltd and ISBI. All rights reserved.

Keywords

• Topical hemostatic; TT-173; Tissue factor; Surgical bleeding; Thrombin