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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/196821
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)
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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.
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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, Sebastià, VILA, Ramon, IBORRA ORTEGA, Elena. 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). _Medicine_. 2022. Vol. 101, núm. 50. [consulta: 26 de febrer de 2026]. ISSN: 0025-7974. [Disponible a: https://hdl.handle.net/2445/196821]