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)

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.