World Journal of Surgery Publishes CleanCision Clinical Data
Novel CleanCision System Reduces Incisional Contamination in Colorectal Surgery
Wound contamination identified as a key culprit behind surgical site infection
SAN CARLOS, Calif., May 21, 2018 /PRNewswire/ -- Prescient Surgical announced publication of clinical data in the World Journal of Surgery on CleanCision, its novel wound retraction and protection system, which received FDA clearance in October of 2017.
Colorectal surgery is known to have high rates of surgical site infection (SSI). Due to the nature of the procedure, there is high likelihood of contamination of the surgical incision site. It has been shown that up to 50% of all abdominal incisions may be contaminated during colon surgery.1
The study demonstrated that use of the CleanCision device resulted in a 66% reduction in overall wound edge contamination from 34.5% to 11.9% (P<0.001). Enteric contamination was also shown to be reduced by 71% (P<0.001). The incisional SSI rate was 2.3% in the primary analysis and 1.2% in those that completed the protocol. There were no adverse events attributed to the device, confirming its safe use.
"We have to continue to explore new technologies and tools that protect patients from infection-causing contamination during surgery," said Dr. Harry Papaconstantinou, MD, Chair, Department of Surgery at Temple, Texas-based Scott & White Medical Center, colorectal surgeon, and lead author and principal investigator in the trial. "This study helps us understand that preventing exposure to bacterial contamination in colorectal surgery can reduce risk of infection. It also spotlights the role of combining irrigation and barrier protection as a new way to continue to lower risk across all of our colorectal surgeries," he added.
"Advancing SSI prevention technique is as important as advancing surgical technique," said Dr. Elisa Birnbaum, MD, Professor of Surgery, University of Colorado Anschultz Medical Campus, colorectal surgeon, and top-enroller in the study. "Even with our rapidly evolving technologies for minimally invasive surgery, the threat of infection, while lessened with these approaches, is still a primary concern. With an advanced, easy to use device such as CleanCision, we can exert more control over the wound site, clearing away bacteria while protecting the wound from exposure. These results are promising and could indicate that this approach has an important role in an enhanced SSI infection prevention bundle," she added.
The study was a prospective, multi-center clinical study in a cohort of elective colorectal surgery patients undergoing a resection. The study was conducted at seven centers in the United States. There were a total of 86 subjects eligible for analysis. Contamination was evaluated by comparing bacterial contamination present on the exposed incision edge compared to the incision edge protected by the device at the time of device removal. Patients were followed for 30 days for evaluation of SSI using the CDC definitions.
1 Fa-Si-Oen PR, Kroeze F, Verhoef LH, Verwaest C, Roumen RM. Bacteriology of abdominal wounds in elective open colon surgery: a prospective study of 100 surgical wounds. Clin Microbiol Infect. 2005;11(2):155-157.