Surgical site infections (SSI) account for a major proportion of hospital-acquired infections. They are associated with longer hospital stay, readmissions, increased costs, mortality, and morbidity. Reducing SSI is a goal of the Surgical Care Improvement Project and identifying interventions that reduce SSI effectively is of interest. In a single-blinded randomized controlled trial (RCT) we evaluated the effect of localized warming applied to surgical incisions on SSI development and selected cellular (immune, endothelial) and tissue responses (oxygenation, collagen).
METHODS:
After Institutional Review Board approval and consent, patients having open bariatric, colon, or gynecologic-oncologic related operations were enrolled and randomly assigned to local incision warming (6 post-operative treatments) or non-warming. A prototype surgical bandage was used for all patients. The study protocol included intra-operative warming to maintain core temperature ≥36°C and administration of 0.80 FIO2. Patients were followed for 6 wks for the primary outcome of SSI determined by U.S. Centers for Disease Control (CDC) criteria and ASEPSIS scores (additional treatment; presence of serous discharge, erythema, purulent exudate, and separation of the deep tissues; isolation of bacteria; and duration of inpatient stay). Tissue oxygen (PscO2) and samples for cellular analyses were obtained using subcutaneous polytetrafluoroethylene (ePTFE) tubes and oxygen micro-electrodes implanted adjacent to the incision. Cellular and tissue ePTFE samples were evaluated using flow cytometry, immunohistochemistry, and Sircol™ collagen assay (Biocolor Ltd., Carrickfergus, United Kingdom).
RESULTS:
One hundred forty-six patients participated (n=73 per group). Study groups were similar on demographic parameters and for intra-operative management factors. The CDC defined rate of SSI was 18%; occurrence of SSI between groups did not differ (p=0.27). At 2 wks, warmed patients had better ASEPSIS scores (p=0.04) but this difference was not observed at 6 wks. There were no significant differences in immune, endothelial cell, or collagen responses between groups. On post-operative days one to two, warmed patients had greater PscO2 change scores with an average PscO2 increase of 9-10 mm Hg above baseline (p