Randomized clinical trial of intradermal suture and metallic stapling for incisional groin closure after vascular surgery (VASC-INF trial).

BACKGROUND

Surgical-site infection (SSI) is a relevant complication in vascular surgery due to its associated morbidity and mortality. However, the optimal type of skin closure (intradermal suture versus metallic staples) to minimize SSI rates has been scarcely studied. The aim of this study was to compare the incidence of SSI associated with intradermal suture versus metallic staples in patients undergoing arterial surgery through a groin femoral approach.

METHODS

A multicentre, open-label, superiority RCT was conducted between April 2022 and January 2024 across three tertiary hospitals (two in Spain and one in Italy). The last-patient, last-visit date was 31 March 2024. Patients were randomized (1 : 1) to receive intradermal sutures (experimental group) or metallic staples (control group) via a computer-generated random sequence prepared by an independent researcher not involved in other aspects of the trial. The primary outcome was the 28-day cumulative incidence of SSI after elective revascularization procedures with inguinal vertical incisions with or without concomitant incisions, assessed per the definitions of the US Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network.

RESULTS

In this trial, 112 patients were randomized to intradermal suture and 113 patients were randomized to metallic staples. SSIs occurred in eight patients in the intradermal suture group (cumulative incidence of 7.1% (95% c.i. 3.7% to 13.5%)) and six patients in the metallic staples group (cumulative incidence of 5.3% (95% c.i. 2.5% to 11.1%)). The relative risk (RR) of SSI was 1.4 (95% c.i. 0.5 to 3.8) times higher in the intradermal suture group, but the results were not statistically significant (P = 0.769). No additional SSIs occurred at 84 days after surgery, and the rates of lymphocele, haematoma, or lymphorrhoea did not differ significantly between groups.

CONCLUSION

Intradermal sutures were not superior to metallic staples in preventing SSIs in patients undergoing vascular surgery through a groin femoral approach.

REGISTRATION NUMBER: NCT05434182 (http://www.clinicaltrials.gov).