Background: The purpose of this prospective, randomized study is to determine whether the preventive negative pressure wound therapy with PICO™ dressing system could reduce wound complications after the standard median sternotomy in cardiac surgery.
Methods: 256 patients undergoing open cardiac surgery during the period July 2019 to July 2023 were prospectively randomized in two groups: 108 patients were treated with PICO™ (Smith and Nephew Ltd, Hull, England) which was applied for 5 to 7 days, whereas 148 patients in control group received conventional wound dressings. Primary endpoints were superficial and deep sternal wound healing disorders, as well as the rate of sternal instability within 7, 30, and 180 days after surgery. Inverse probability of treatment weighting (IPTW) was used to assess the impact of PICO™ on wound complications.
Results: After randomization, baseline and procedural characteristics were similar in both groups. In the PICO group the incision was primarily closed in 102 (94.4%) patients and there were seven cases (95.3%) of superficial dehiscence in the control group after 7 days of treatment. The overall 30-day incidence of sternal wound healing disorders was similar in both groups (17 [15.7%] versus 21 [14.2%], p = 0.726). 180 days after surgery, two patients in each group showed a skin dehiscence, while two patients in the PICO group had an instable sternum. Statistically, significantly less wound healing problems occurred in the PICO compared with the conventional group within 7 days after surgery (OR 2.1, 95%CI [1.016 to 4.369], p = 0.045), but not on 30 and 180 days after surgery, respectively (OR 1.0, 95%CI [0.472 to 2.247], p = 0.942 and OR 6.7, 95%CI [0.685 to 66.098], p = 0.102).
Conclusion: The initial superiority of the PICO™ system to prevent wound infections following open-heart surgery could not be maintained at the 30- and 180-day follow-up.
