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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)
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 b...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9771231/ https://www.ncbi.nlm.nih.gov/pubmed/36550867 http://dx.doi.org/10.1097/MD.0000000000031800 |
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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, Elena |
author_facet | 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, Elena |
author_sort | González-Sagredo, Albert |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9771231 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-97712312022-12-22 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) 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, Elena Medicine (Baltimore) 7100 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. Lippincott Williams & Wilkins 2022-12-16 /pmc/articles/PMC9771231/ /pubmed/36550867 http://dx.doi.org/10.1097/MD.0000000000031800 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | 7100 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, 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) |
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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | 7100 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9771231/ https://www.ncbi.nlm.nih.gov/pubmed/36550867 http://dx.doi.org/10.1097/MD.0000000000031800 |
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