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.

A Janus adhesive hydrogel sheet for preventing postoperative tissue adhesion of intestinal injuries

“…Surgical sutures have served as the universal method for wound closure in the clinic; however, stitching suffers from some adverse disadvantages, including being time-consuming and difficult to operate, as well as causing secondary tissue damage. [1][2][3] More recently, tissue adhesives have attracted increasing attention as alternatives to sutures owing to advantages such as time savings, simple operation, and noninvasivity in terms of tissue damage, avoiding suture-related complications. [4][5][6][7][8] While there are numerous emerging bioadhesive hydrogels, most of them are double-sided adhesives without different adhesion on different surfaces, suffering from unfavorable postoperative tissue adhesion caused by excessive tissue adhesion during the operation process, thus limiting their clinical application in intestinal repair.…”