Proposed Classification of Incision Complications: Analysis of a Prospective Study on Elective Open Lower-Limb Revascularization

Abstract

Background: Incision complications (IC) have a significant impact on procedure-related morbidity after lower-limb revascularization. One of the most studied IC is surgical site infection (SSI). Reporting these complications in a uniform way is crucial to evaluate treatment approaches. The aim of this study was to propose a comprehensive classification of IC and apply it to compare SSI with other IC in a trial on elective open lower-limb revascularization procedures. Methods: Two hundred twenty-three eligible patients undergoing elective unilateral inguinal and infra-inguinal arterial vascular surgery were extracted from a randomized controlled trial on incisional negative-pressure wound therapy (NPWT) on inguinal vascular surgical incisions. The IC were classified by grades of severity (grade 0-6) that focused on IC-related consequences such as out-patient treatment (grade 1), prolonged in-patient treatment (grade 2), re-admission (grade 3), and re-operation (grade ≥4). An SSI was defined by the ASEPSIS score criteria. Results: An SSI was diagnosed in 63 patients (28.3%). Thirty-five of 160 patients (21.8%) not suffering from SSI underwent IC treatment. Treatment for IC was recorded for 25/144 patients (17.4%) with satisfactory site healing as judged by the ASEPSIS score. The median incision-related in-hospital stay in those with SSI (n = 79) and disturbed healing (n = 16) according to the ASEPSIS score was 13 days in both groups (p = 0.53). Five patients had peri-vascular SSI (IC grade 4 n = 4; grade 5 n = 1). The proposed classification of IC and the ASEPSIS score correlated highly (r = 0.77; p < 0.001). Inter-rater reliability for IC grading was substantial for three investigators with different levels of experience (k = 0.81, 0.71, and 0.70). Conclusions: The proposed incision classification suggests a comparable clinical significance of vascular IC in terms of IC-related in-patient stay, whether there was a surgical site infection or not. This classification system requires external validation.