• Burns · Jun 2017

    Randomized Controlled Trial Multicenter Study

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

    • Santiago Rojas, M Dolores Pérez Del Caz, Juan Ramón Esteban Vico, Eloísa Villaverde, Abel Llinas, José Ramón Martínez, Carlos Brage, Javier Valero, Alba González Rodríguez, Juan Garcia Barreiro, Eugenia López-Suso, Jose Luis Fernandez-Cañamaque, Ramón López, Jesus Murat, and EHTIC Study Investigators Group.
    • 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.
    • Burns. 2017 Jun 1; 43 (4): 780-788.

    BackgroundExcessive 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.MethodsEHTIC 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.ResultsTreatment 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.ConclusionThe 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.Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…