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

BMC Surgery

Research

Maria Teresa Iglesias-Gaspar¹  Iratxe Urreta-Ballobre¹  José María Enríquez-Navascués²  Amaia García-Domínguez³  Maialen Alkorta-Zuloaga⁴  Miguel Ángel Medrano-Gómez⁴  Inmaculada Ruiz-Montesinos⁴  Xabier Arteaga-Martin⁴  Ignacio Aguirre-Allende⁴  Adolfo Beguiristain-Gómez⁴  Ana Paula Riverola-Aso⁴  Raúl Jiménez-Agüero⁴ 

[1] Clinical Epidemiology Unit, Donostia University Hospital-IHO Donostialdea, IIS Biodonostia, Paseo Doctor Beguiristain S/N, 20014, Donostia-San Sebastian, Spain;General and Digestive Surgery Department, Colorectal Surgery Unit, Donostia University Hospital-IHO Donostialdea, IIS Biodonostia, Paseo Doctor Beguiristain S/N, 20014, Donostia-San Sebastian, Spain;General and Digestive Surgery Department, Donostia University Hospital-IHO Donostialdea, IIS Biodonostia, Paseo Doctor Beguiristain S/N, 20014, Donostia-San Sebastian, Spain;General and Digestive Surgery Department, Hepatobiliary and Pancreatic Surgery Unit, Donostia University Hospital-IHO Donostialdea, IIS Biodonostia, Paseo Doctor Beguiristain S/N, 20014, Donostia-San Sebastian, Spain;

关键词: Surgical-site infection;    Subcuticular suture;    Surgical staples;    Hepatobiliary surgery;    Pancreatic surgery;   

DOI  :  10.1186/s12893-023-01911-0

 received in 2022-10-16, accepted in 2023-01-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSubcuticular 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 if subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery.MethodsSingle-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.ResultsOf the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n = 173) or subcuticular suture (n = 173). After further 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).ConclusionsSubcuticular 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).

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

41116_2022_35_Article_IEq446.gif

41116_2022_35_Article_IEq444.gif