Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

Surgical Site Infections Clinical Trial

— PICS-Prevena  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03402945
• Other study ID #: PICS-PREVENA V1_20171106
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 5, 2018
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4107
• Est. completion date: June 2024
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies)

Exclusion Criteria:

• On systemic antibiotics or with an active bacterial infection at the time of surgery

• Patients previously enrolled in this trial

• Patients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena

• Participation in other studies that may interfere with this trial

Related Conditions & MeSH terms

• Infections
• Surgical Site Infections
• Surgical Wound Infection

Intervention

Device:
• Prevena
Negative-Pressure Wound Management System

Drug:
• Cefazolin
antibiotic
• 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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Centre & Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Connolly SJ, Philippon F, Longtin Y, Casanova A, Birnie DH, Exner DV, Dorian P, Prakash R, Alings M, Krahn AD. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: design of the Prevention of Arrhythmia Device Infection Trial (PADIT). Can J Cardiol. 2013 Jun;29(6):652-8. doi: 10.1016/j.cjca.2013.01.020. Erratum In: Can J Cardiol. 2013 Jul;29(7):889. — View Citation

Edwards FH, Engelman RM, Houck P, Shahian DM, Bridges CR; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration. Ann Thorac Surg. 2006 Jan;81(1):397-404. doi: 10.1016/j.athoracsur.2005.06.034. No abstract available. — View Citation

Filsoufi F, Castillo JG, Rahmanian PB, Broumand SR, Silvay G, Carpentier A, Adams DH. Epidemiology of deep sternal wound infection in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):488-94. doi: 10.1053/j.jvca.2009.02.007. Epub 2009 Apr 19. — View Citation

Lador A, Nasir H, Mansur N, Sharoni E, Biderman P, Leibovici L, Paul M. Antibiotic prophylaxis in cardiac surgery: systematic review and meta-analysis. J Antimicrob Chemother. 2012 Mar;67(3):541-50. doi: 10.1093/jac/dkr470. Epub 2011 Nov 13. — View Citation

Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011 Jul;254(1):48-54. doi: 10.1097/SLA.0b013e318214b7e4. — View Citation

Mertz D, Whitlock R, Kokoszka AY, Smith SW, Carignan A, Rehan M, Jaffer IH, Alsagheir A, Loeb M. Routine Surveillance Versus Independent Assessment by an Outcome Adjudication Committee in Assessing Patients for Sternal Surgical Site Infections After Cardiac Surgery. Infect Control Hosp Epidemiol. 2016 May;37(5):600-2. doi: 10.1017/ice.2015.347. Epub 2016 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the wound management system	goal is >90%	Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery
Primary	Adherence to the antibiotic regimen	goal is >90%	Cefazolin: within an hour of surgery; one intra-operative dose at 4 hours after the first dose or upon wound closure (whatever comes first); two post-operative doses q8h. Vancomycin: initially intravenously; second dose 12 hrs after the first dose.
Primary	Loss of follow-up	goal is <10%	up to 90 days after surgery
Secondary	Deep incisional and organ/space sternal-surgical site infection (s-SSI)	using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions	up to 90 days after surgery
Secondary	Wound dehiscence	using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions	up to 90 days after surgery
Secondary	C. difficile infection	laboratory confirmed	up to 90 days after surgery
Secondary	Mortality in patients with an active infection	using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions	up to 90 days after surgery
Secondary	ICU (Intensive Care Unit) and hospital stay	length	Length of ICU - from date of surgery to initial ICU discharge date, assessed up to 90 days after surgery. Hospital Stay - date of surgery to date of hospital discharge, assessed up to 90 days after surgery.
Secondary	Pain on day 7	Visual analog scale (VAS)	Pain at Day 7 (+/- 1 day)
Secondary	Acute kidney injury	Based on serum creatinine, following Acute Kidney Injury Network definition	within 7 days of surgery