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Title: | 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) |
Author: | González-Sagredo, Albert Gil, Miquel D'Oria, Mario Spanos, Konstantinos Salinas, Álvaro Matus, Selene Carnaval, Thiago Llagostera, Secundino Lepidi, Sandro Giannoukas, Athanasios Bellmunt, Sergi García-Vidal, Raul Videla, Sebastián Vila, Ramon Iborra Ortega, Elena |
Keywords: | Sutures (Cirurgia) Infeccions quirúrgiques Cirurgia vascular Sutures (Surgery) Surgical wound infection Vascular surgery |
Issue Date: | 25-Oct-2022 |
Publisher: | Lippincott, Williams & Wilkins. Wolters Kluwer Health |
Abstract: | Background: Surgical 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. Methods: VASC-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. Discussion: Intradermal 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1097/MD.0000000000031800 |
It is part of: | Medicine, 2022, vol. 101, num. 50 |
URI: | http://hdl.handle.net/2445/196821 |
Related resource: | https://doi.org/10.1097/MD.0000000000031800 |
ISSN: | 0025-7974 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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