PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)

What this Trial Is About

Researchers are evaluating whether negative pressure wound therapy using the PICO device on closed groin incisions after vascular surgery can lower the risk of surgical site infections and other wound problems. This randomized trial focuses on patients undergoing elective vascular procedures, separating cases into two groups based on the type of surgery: endovascular aortic repair (EVAR) and open vascular surgery. The study was designed after noting a high infection rate of 22.9% in groin wounds following vascular surgery. Participants receive either standard wound dressings or the PICO negative pressure wound therapy on their groin incisions. The study includes two arms: one for EVAR surgery and one for open vascular surgery. The EVAR arm requires 497 groin incisions to assess a reduction in infection rates, while the open surgery arm needs 147 incisions. This trial is conducted across multiple centers to gather sufficient data. During the study, wounds will be checked at a 3-month follow-up to measure infection rates using an objective tool. Researchers will also evaluate the overall treatment costs at this time. Participants provide written informed consent and are monitored for wound healing and complications. The trial is led by Stefan Acosta and funded by public Swedish sources and Smith & Nephew, with the study ongoing since 2013.

PICO Above Incisions After Vascular Surgery