Insoo Suh, MD1, Jonathan Coe, MS2, Jeremy Koehler, MS2, Mark L Welton, MD3. 1University of California, San Francisco, 2Prescient Surgical, Inc, 3Stanford University
Objective of the Technology
Surgical site infection (SSI) after colorectal procedures is a major cause of patient morbidity and health care costs. The frequency of SSI remains high despite existing preventative measures, underscoring the clinical need and opportunity for promising new technologies. Recently, we developed a novel surgical device for preventing intraoperative contamination and SSI in abdominal surgery. We evaluated this device's local microbiological effects and clinical feasibility in a large animal surgical model and in colorectal surgery patients.
Description of the Technology and Method of its Application
Our technology integrates continuous intraoperative wound irrigation into a user-friendly barrier wound protection device. To study the local microbiological effects of this device, we performed a simulated colorectal procedure on seven adult female pigs. The abdominal cavity was contaminated with a solution containing 1×109 colony-forming units (CFU) of gentamicin-sensitive Escherichia coli, and the device was tested with and without irrigation with a solution of 240 g/L gentamicin in normal saline. Wound swabs, wound-edge tissue blocks, and peripheral blood samples were taken when the incision was closed, as well as 4 hours afterward with the incision re-opened. Culture analysis was performed, in addition to histology/immunohistochemistry of the incision-edge tissue as well as serum gentamicin concentrations. For evaluation of clinical feasibility, the device was tested in six adult patients undergoing open elective colorectal operations (Figure). Surgeons completed post-operative surveys on usability, and adverse events at 30 days were recorded.
Microbiological evaluation revealed that incisional wound tissue protected by the device had exponentially lower levels of E. coli growth compared to exposed tissue (2.0×102 vs 4.0×105 CFU/g). Use of gentamicin irrigation produced significant and prolonged protection against intraoperative contamination, with a 2-log reduction in mean postoperative E. coli concentrations compared with the device used only as a wound protector without irrigation (2.1×102 vs 2.6×104 CFU/g, p=0.04). Histological and immunohistochemical analysis revealed no apparent injury to the wound edge tissue due to device use. Serum gentamicin levels remained far below clinically-relevant thresholds and decreased over time. On clinical evaluation, the device was rated highly by surgeons on ease of use, adequacy of wound protection, and compatibility with use of other surgical instruments. Tissue injury due to the device was not observed, and no device-related adverse events occurred during the follow-up period.
The use of a novel irrigating wound protection device in colorectal operations prevents intraoperative contamination and post-operative microbial proliferation in a large animal model, and demonstrates promise as a clinically-feasible technology. Clinical trials are currently underway to validate the findings from this study and further support this device’s benefit in the prevention of SSI.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 84311
Program Number: ETP752
Presentation Session: Emerging Technology Poster
Presentation Type: Poster