Subcuticular suture and incisional surgical-site infection in elective hepatobiliary and pancreatic surgery: an open-label, pragmatic randomized clinical trial (CLOSKIN trial)

Abstract

Background: subcuticular suture has proven to reduce superficial incisional SSI (si-SSI) in clean surgery. However, question remains regarding clean-contaminated procedures. The aim of this study is to assess that subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery. Methods: single-centre, open-label, parallel, pragmatic randomized clinical trial conducted at a referral tertiary Hospital between January 2020 and April 2022. Patients eligible for elective HBP surgery were randomly assigned (1:1) to subcuticular suture or surgical staples wound closure using a minimisation method based on previously confirmed risk factors. The primary endpoint was the incidence of si-SSI. Considered secondary endpoints were major postoperative morbidity in both groups, additional wound complications, median hospital length of stay and need for re-hospitalisation. Results: Of the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n= 173) or subcuticular suture (n= 173). After exclusion of 11 participants, 167 and 168 patients respectively in the control and the experimental group received their allocated intervention. For the primary endpoint, no significant differences in si-SSI rate were found: 17 (9.82%) staples group vs. 8 (4.62%) in subcuticular suture group (p= 0.062). Subset analysis confirmed absence of significant differences. As for secondary endpoints, overall wound complications did not differ significantly between two procedures: 19 (10.98%) vs. 10 (6.35%) (p= 0.127). There were no treatment related adverse events. However, occurrence of si-SSI contributed to major postoperative morbidity in both groups (p< 0.001 and p= 0.018) and to a substantially prolonged postoperative hospitalization (p= 0.015). Conclusions: subcuticular suture might offer a relative benefit for skin closure reducing incidence of si-SSI after elective HBP surgery, although this was found not to be clinically relevant. Yet, this should not be interpreted as equivalence among both treatments. Therefore, wound closure strategy should not be based only on these grounds. Trial registration number: ISRCTN Registry number ISRCTN37315612 (registration date: 14/01/2020)