HYPOChLorous Acid TEsting Studies in elective groin VASCULAR surgery (HYPOCLATES:VASCULAR): protocol for an ambispective cohort study evaluating a standard change to hypochlorous acid lavage in patients undergoing elective groin vascular surgery.

内容摘要

Surgical site infections remain a frequent and clinically relevant complication following elective open vascular groin surgery, particularly in procedures involving implantation of alloplastic material. Despite routine use in many surgical disciplines, the role of standardized intraoperative wound irrigation in vascular groin surgery is insufficiently defined. Hypochlorous acid is a physiologically occurring antimicrobial agent with broad-spectrum activity and favourable tissue compatibility, making it a promising option for intraoperative wound lavage. However, clinical evidence for its preventive use in elective vascular groin procedures is limited. Hypoclates:vascular is a single-centre, ambispective cohort study conducted at Heidelberg University Hospital. Adult patients undergoing elective open vascular groin surgery with arterial exposure are included. A departmental standard change introduced intraoperative wound irrigation with at least 250 ml hypochlorous acid-containing Granudacyn® prior to wound closure, with additional irrigation of alloplastic material where applicable. Patients treated before this change form a retrospective control cohort without antiseptic lavage, while those treated thereafter constitute the prospective cohort. The primary outcome is the incidence of surgical site infections classified according to Centers for Disease Control and Prevention criteria. Secondary outcomes include postoperative morbidity, wound-related complications, antibiotic use, length of hospital stay, and overall morbidity assessed by the Comprehensive Complication Index. Multivariable logistic regression will be used to explore associations between hypochlorous acid-based irrigation and infectious outcomes. This study provides a pragmatic real-world evaluation of standardized hypochlorous acid-based intraoperative wound irrigation in elective open vascular groin surgery. The results will clarify whether this physiologically compatible antiseptic approach is associated with reduced surgical site infections and postoperative morbidity, thereby informing the design of future randomized trials and evidence-based perioperative standards in vascular surgery. The study was registered on 25 March 2026 in the German Clinical Trials Register (registration identifier: DRKS00039521) prior to data acquisition.