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

Area of Science:

• Cardiothoracic Surgery
• Infectious Disease
• Wound Management

Background:

• Sternal surgical site infections (SSIs) pose significant risks after cardiac surgery.
• The impact of negative pressure wound management (NPWM) and vancomycin prophylaxis on SSIs remains unclear.

Purpose of the Study:

• To investigate the feasibility of implementing NPWM (3M Prevena) and assess adherence to protocols in a cardiac surgery setting.
• To explore the preliminary effects of NPWM on deep/organ-space sternal SSIs in obese or diabetic patients.

Main Methods:

• A 2x2 factorial, open-label, cluster-randomized crossover trial involving two hospitals.
• Patients were allocated to standard wound dressing or NPWM (Prevena), with a focus on obese/diabetic participants.
• Feasibility metrics included protocol adherence (>90% goal) and loss to follow-up (<10% goal).

Main Results:

• Protocol adherence for wound management was 68.1%, below the target, with significant site variation.
• Loss to follow-up was 3.6%, meeting the goal.
• Deep/organ-space SSIs occurred in 1.6% of patients with Prevena and 1.4% with standard dressing (OR=1.11, 95% CI: 0.56-2.20).

Conclusions:

• The vanguard trial highlighted challenges in introducing novel wound care technology into standard practice.
• Non-compliance, primarily at one site, impacted feasibility assessments.
• The study was not powered for clinical efficacy, and no firm conclusions on Prevena's effectiveness can be drawn.