• Medicine · Dec 2022

    Groin surgical site infection incidence in vascular surgery with intradermal suture versus metallic stapling skin closure: A study protocol for a pragmatic open-label parallel-group randomized clinical trial (VASC-INF trial).

    • Albert González-Sagredo, Miquel Gil, Mario D'Oria, Konstantinos Spanos, Álvaro Salinas, Selene Matus, Thiago Carnaval, Secundino Llagostera, Sandro Lepidi, Athanasios Giannoukas, Sergi Bellmunt, Raul García-Vidal, Sebastián Videla, Ramon Vila, and Elena Iborra.
    • Angiology and Vascular Surgery Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
    • Medicine (Baltimore). 2022 Dec 16; 101 (50): e31800e31800.

    BackgroundSurgical site infection is 1 of the most frightening complications in vascular surgery due to its high morbimortality. The use of intradermal sutures for skin closure might be associated with a reduction in infections incidence. However, the data available in the literature is scarce and primarily built on low-evidence studies. To our knowledge, no multicenter clinical trial has been published to assess if the intradermal suture is associated with a lower surgical site infection incidence than metallic staples in patients who will undergo revascularization surgery requiring a femoral approach.MethodsVASC-INF is a pragmatic, multicenter, multistate (Spain, Italy, and Greece), randomized, open-label, clinical trial assessing the surgical site infection incidence in patients undergoing revascularization surgery requiring a femoral approach. Patients will be randomized on a 1:1 ratio to intradermal suture closure (experimental group) or to metallic staples closure (control group).The primary outcome is the number (percentage) of patients with surgical site infection (superficial and/or deep) associated with a femoral approach up to 28 (±2) days after surgery. Among the secondary outcomes are the number (percentage) of patients with other surgical wound complications; the number (percentage) of patients with surgical site infections who develop sepsis; type of antibiotic therapy used; type of microorganisms' species isolated and to describe the surgical site infection risk factors.DiscussionIntradermal suture closure may be beneficial in patients undergoing revascularization surgery requiring a femoral approach. Our working hypothesis is that intradermal suture closure reduces the incidence of surgical site infection respect to metallic staples closure.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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