NCT03402945

Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

A Cluster-randomized Factorial Crossover Trial, Comparing Antibiotic Mono-prophylaxis With Cefazolin vs. Dual-prophylaxis With Cefazolin Plus Vancomycin and Conventional Wound Dressing vs. Prevena Negative-pressure Wound Management

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,107 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.

Detailed description

Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. The best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. A large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. Appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. The proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
DEVICE	Prevena	Negative-Pressure Wound Management System
DRUG	Cefazolin	antibiotic
DRUG	Vancomycin	antibiotic
OTHER	standard wound dressing	Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.

Timeline

• Start date: 2018-03-05
• Primary completion: 2023-04-27
• Completion: 2024-10-17
• First posted: 2018-01-18
• Last updated: 2025-02-28

Locations

2 sites across 1 country: Canada