Introduction: Surgical site infection is one of the most frightening complications in vascular surgery, due to its high morbimortality. There are retrospective studies showing that intradermal sutures might be associated with lower infection rates, compared to staples. To our knowledge, no multicenter clinical trial has been published on this topic. The primary objective of the study is to assess if skin closure with intradermal

sutures is associated with lower surgical site infection incidence, compared to staples, at 28 days after surgery.

Methods: Pragmatic open-label parallel-group multicenter randomized clinical trial. The study received the approval of the Ethics Committee (PR047/22) and the protocol was published in Medicine. Patients were randomized (1:1 ratio) to intradermal suture (experimental group) or metallic staples (control group). The sample size was 224 patients, assuming 80% power, 5% alfa error and 10% dropout. The statistical analysis was performed by intention-to-treat, with R® 4.1.0 Windows® (Core [2020]). The main variable was evaluated by Chi-square test and was estimated the relative risk and its confidence interval of 95%.

Results: A total of 113 patients were randomized to the control group and 112 to the experimental group. There were no significant differences regarding their basal characteristics. The cumulative incidence of surgical site infection at 28 days was of 5.3% (6/113, IC95%: 2.5-11.1) in the control group and 7.1% (8/112, IC95%: 3.7-13.5) in the experimental group (RR 1.35, IC95%: [0.48-3.75]; p-valor=0.769).

Conclusion: Intradermal suture is not associated with a reduction in surgical site infection incidence for femoral approach compared to metallic staples.

To be updated