Prevention of Infections in Cardiac Surgery (PICS)-Prevena Study – A pilot/vanguard factorial cluster cross-over RCT

by Thomas C. Scheier, Richard Whitlock, Mark Loeb, Philip James Devereaux, Andre Lamy, Michael McGillion, MacKenzie Quantz, Ingrid Copland, Shun-Fu Lee, Dominik Mertz

Sternal surgical site infections after cardiac surgery can lead to significant morbidity, mortality, and cost. The effects of negative pressure wound management and adding vancomycin as perioperative antimicrobial prophylaxis are unknown. The PICS-PREVENA pilot/vanguard trial, a 2x2 factorial, open label, cluster-randomized crossover trial with 4 periods, was conducted at two major cardiac surgery hospitals in Ontario, Canada. Sites were randomized to one of eight sequences of the four study arms (Cefazolin or Cefazolin + Vancomycin (not analyzed) and standard wound dressing or a negative pressure 3M Prevena incision management system (Prevena). Only diabetic or obese patients were eligible for the latter comparison. This trial investigated feasability including adherence to protocol of each intervention (goal: > 90% each) and loss to follow-up (goal: