FDA approves CleanCision Wound Retraction and Protection System to protect and irrigate surgical wounds-Prescient Surgical

The FDA's Center for Devices & Radiological health granted de novo clearance for Prescient Surgical's CleanCision Wound Retraction and Protection System from Prescient Surgical for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant solution. The CleanCision device may also aid in the prevention of wound edge contamination, a powerful advance towards mitigating associated infections.

The CleanCision device, the first in a new category of irrigating wound protection devices classified by the FDA, provides access to the surgical site while protecting the incision with an impermeable barrier, defending against direct contamination. The device also facilitates intraoperative delivery of a sterile irrigant solution of the surgeon's choice to the wound edge. With CleanCision, wound irrigation and wound protection, two independently proven strategies to prevent surgical site infection, are seamlessly combined into a single device.

Comment: Studies have shown that surgical site infection costs about $21,000 on average to treat, increasing hospital stays by about 10 days. While overall about 2 to 5 percent of those undergoing inpatient surgery get these infections, that rate can rise up to 26 percent with abdominal GI operations like colorectal surgery.