Discussion
blood loss, HBP diseases, comorbidity
HBP, BLOOD LOSS, MINOR, CATHETER RELATED INFECTION, SURGICAL SITE INFECTION, HOSPITAL-ACQUIRED PNEUMONIA, URINARY TRACT INFECTION
In this RCT we investigated the incidence of si-SSI in patients undergoing regular elective HBP procedures, comparing subcuticular suturing for surgical wound closure versus conventional staples. All procedures were conducted in a dedicated HBP unit, with both groups of patients following the same perioperative management protocol including a bundle of preventive interventions for si-SSI endorsed by Surgical Site Infection panel of the Spanish Surgical Association [The efficacy of subcuticular suture on reduction of si-SSI has been widely investigated. Subcuticular suturing is accepted as the procedure of choice for clean surgical procedures (wound class 1 according to the CDC criteria) [Several observational and some randomized studies have published a potential benefit of subcuticular suture in the prevention of si-SSI in patients undergoing elective clean-contaminated or contaminated surgery [When the present study was already registered and actively recruiting patients for one year, a meta-analysis of randomized studies [Elective surgery for HBP diseases is associated with prolonged operative time, blood loss, and frequent comorbidity due to patients’ baseline clinical characteristics, which may make the risk of si-SSI differ from other gastrointestinal surgeries [In 2018 two relevant observational propensity-matched cohort studies were published. Both evaluated effect of subcuticular suture on si-SSI in elective HBP surgery [Our study included a comprehensive population based on regular HBP elective procedures, considering all surgical approaches along with a broad spectrum of surgery indications. Furthermore, to our knowledge, this is the only randomized study evaluating si-SSI in HBP surgery that incorporated a specific perioperative protocol encompassing a bundle of validated preventive measures for si-SSI endorsed by leading scientific surgical expert panels. Therefore, the strength of this randomized controlled trial (CLOSKIN trial) is that it provides comprehensive pragmatic evidence on the prevention of si-SSI in relation to the method of wound closure in elective HBP surgery.The present study has several limitations. The research design did not consider the influence of surgical wound length on si-SSI as a possible risk factor, although it considered major open surgery and laparoscopic approach individually as reported in subset analysis. As expected, due to the pragmatic nature of the present randomized clinical trial, a minor group of patients required antibiotic therapy due to other indications besides si-SSI (i.e., urinary tract infection, hospital-acquired pneumonia, or central venous catheter related infections). Although systematic use of antibiotics has not proven to prevent si-SSI, it must be acknowledged that this could have influenced si-SSI incidence. In the same line raising awareness and compliance with hand wash by health care professionals during SARS-CoV-2 pandemic might have led in some point to a decrease in overall si-SSI rate. Nonetheless, it is expected that this would have affected equally to both study groups. Additionally, although the overall compliance with the preventive care bundle for si-SSI was recorded, no information regarding compliance of certain individual measures was obtained. The assessment of si-SSI was performed according to the CDC definition and criteria for si-SSI [