Impact of a Novel Surgical Wound Protection Device on Observed versus Expected Surgical Site Infection Rates after Colectomy Using the National Surgical Quality Improvement Program Risk Calculator
Article
Papaconstantinou, Harry T.; Birnbaum, Elisa H.; Ricciardi, Rocco; Margolin, David A.; Moesinger, Robert C.; Lichliter, Warren E.; Thomas, J. Scott; Bergamaschi, Roberto
Abstract
Background: Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery. A novel surgical device that combines barrier surgical wound protection and continuous surgical wound irrigation was evaluated in a cohort of elective colorectal surgery patients. A retrospective analysis was performed comparing rates of SSI observed in a prospective cohort study with the predicted rate of SSI using the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Risk Calculator. Patients and Methods: A prospective multi-center study of colectomy patients was conducted using a study device for surgical site retraction and protection, as well as irrigation of the incision. Patients were followed for 30 days after the surgical procedure to assess for SSI. After completion of the study, patients' characteristics were inserted into the ACS-NSQIP Risk Calculator to determine the predicted rate of SSI for the given patient population and compared with the observed rate in the study. Results: A total of 108 subjects were enrolled in the study. The observed rate of SSI in the prospective study using the novel device was 3.7% (4/108). The predicted rate of SSI in the same patient population utilizing the ACS-NSQIP Risk Calculator was estimated to be 9.5%. This demonstrated a 61% difference (3.7% vs. 9.5%, p=0.04) in SSI from the NSQIP predicted rate with the use of the irrigating surgical wound protection and retraction device. Conclusions: These data suggest the use of a novel surgical wound protection device seems to reduce the rate of SSIs in colorectal surgery.
