The purpose of the study, conducted by Dr. J. Scott Thomas, associate professor of surgery at the Texas A&M University Health Science Center College of Medicine and Baylor Scott & White Health and co-author of the poster presented at the American Society of Colorectal Surgeons, was to determine if the new irrigating wound protection therapy could aid in lowering the typically high surgical site infection rates of colorectal surgery.
The study evaluated 30-day SSI outcomes for CleanCision, the novel wound retraction device that combines barrier protection and continuous intraoperative wound irrigation, against the standard wound protector used at Baylor Scott & White Health.
A total of 38 subjects were treated with CleanCision between 2015 and 2019 with 102 control-matched subjects identified during the same period. No significant difference existed between control-matched variables with exception of steroid use, which was significantly higher in the novel retractor group. Steroid use has been shown to increase risk for SSI. Overall SSI rates were significantly lower in the novel retractor group at 30-day follow-up (0% versus 11.8%), representing a 100% reduction in SSI risk compared to previous best practices employed at the institution.
“We see that the combination of wound irrigation, protection, and retraction into a single therapy delivered intraoperatively, shows promise as an effective means to reducing the high rates of SSI associated with colorectal surgeries,” said Dr. Thomas. “While these data have some limitations, they are particularly encouraging since the standard wound protector group and the CleanCision group enrollment occurred during the same time period, removing the temporal bias often associated with retrospective studies. In addition, the fact that the novel device cohort featured higher steroid use, which is associated with higher SSI risk, adds to the significance of these findings.”
“These data provide a strong basis for hospitals to standardize the use of irrigating wound protection therapy for abdominal surgeries,” said Jonathan Coe, president, CEO and co-founder of Prescient Surgical. “It’s inspiring to work with so many dedicated surgeons and infection control experts across the country as they continuously strive to advance infection control protocols and improve patient safety.”