title: EHTIC study: Evaluation of a new hemostatic agent based on tissue factor in skin grafting procedures.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Thombotargets Europe, S.L., Parque Mediterráneo de la Tecnología, Castelldefels, Spain; Unit of Human Anatomy and Embryology, Department of Morphological Sciences, Faculty of Medicine, Autonomous University of Barcelona, Cerdanyola del Vallès, Spain. Electronic address: santiagorojas@thrombotargets.com.
authors.forename: Santiago
authors.initials: S
authors.lastname: Rojas
authors.affiliation: Department of Plastic Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain.
authors.forename: M Dolores
authors.initials: MD
authors.lastname: Pérez Del Caz
authors.affiliation: Department of Plastic Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain.
authors.forename: Juan Ramón
authors.initials: JR
authors.lastname: Esteban Vico
authors.affiliation: Department of Plastic Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain.
authors.forename: Eloísa
authors.initials: E
authors.lastname: Villaverde
authors.affiliation: Department of Plastic Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain.
authors.forename: Abel
authors.initials: A
authors.lastname: Llinas
authors.affiliation: Department of Plastic Surgery, La Paz University Hospital, Madrid, Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Martínez
authors.affiliation: Department of Plastic Surgery, La Paz University Hospital, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Brage
authors.affiliation: Department of Plastic Surgery, University Hospital Complex of A Coruña, A Coruña, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Valero
authors.affiliation: Department of Plastic Surgery, University Hospital Complex of A Coruña, A Coruña, Spain.
authors.forename: Alba
authors.initials: A
authors.lastname: González Rodríguez
authors.affiliation: Department of Plastic Surgery, University Hospital Complex of A Coruña, A Coruña, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Garcia Barreiro
authors.affiliation: Department of Plastic Surgery, University Hospital Complex of A Coruña, A Coruña, Spain.
authors.forename: Eugenia
authors.initials: E
authors.lastname: López-Suso
authors.affiliation: Department of Plastic Surgery, University Hospital of Getafe, Getafe, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Fernandez-Cañamaque
authors.affiliation: Thombotargets Europe, S.L., Parque Mediterráneo de la Tecnología, Castelldefels, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: López
authors.affiliation: Thombotargets Europe, S.L., Parque Mediterráneo de la Tecnología, Castelldefels, Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: Murat
mesh_terms: D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002056:Burns / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use*; D016038:Skin Transplantation / Q000379:methods*; D013925:Thromboplastin / Q000627:therapeutic use*; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000601:surgery
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; D013925:Thromboplastin
keywords: Surgical bleeding; TT-173; Thrombin; Tissue factor; Topical hemostatic