FDA approved ‘CleanCision’ Wound Retraction and Protection System that helps reduce surgical site infections

The CleanCision Wound Retraction and Protection SystemTM is an investigational device combining the features of self-retaining retraction, barrier wound protection, and continuous wound edge irrigation during abdominal surgical procedures. The device provides access to the abdominal cavity, and wound edge irrigation is provided by a double-walled barrier sheath that integrates fluid delivery and removal functionality.

The FDA’s Center for Devices & Radiological health granted de novo clearance for Prescient Surgical’s CleanCision Wound Retraction and Protection System 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.

The timing of the de novo clearance is fortuitous. According to Brant Heise, Managing Director at Summation Health Ventures, “Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient’s success with the CleanCision device bodes well for providers driven towards the ‘triple aim’ of quality of care, patient satisfaction, and reduced costs.

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CleanCision Wound Retraction and Protection System. Want to reduce surgical site infections

Fluid is delivered to the wound edges via gravitational feed from an external fluid bag into the device and through the permeable outer layer of the integrated sheath. After contacting the wound edge, excess fluid is removed through a separate chamber within the sheath via connection to wall suction. The inner layer of the sheath is impermeable to fluids present in the surgical field.

 

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