Evidence map›Paper›PMID 41397003›Full record

Trial reportPloS one2025

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

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

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Thomas C ScheierPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Richard WhitlockPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Mark LoebPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Philip James DevereauxPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Andre LamyPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Michael McGillionPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
MacKenzie QuantzDepartment of Surgery, Division of Cardiac Surgery, Schulich School for Medicine & Dentistry, London, ON, Canada.
Ingrid CoplandPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Shun-Fu LeePopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Dominik MertzPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0003-4337-1613

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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: < 10%). Among the 4107 included patients, 2230 were obese/diabetic (1208 standard wound dressing period, 1022 during Prevena period). Compliance to wound management and antimicrobial prophylaxis was 68.1% and 98.7%, respectively. Loss to follow-up was 3.6%. Deep/organ-space sternal surgical site infections occurred in 16 (1.6%) patients in the Prevena allocated periods and in 17 (1.4%) patients in the standard wound dressing allocated periods (OR= 1.11, 95% CI: 0.56-2.20). Other clinical outcomes did not suggest a difference and a post-hoc as-treated analysis showed similar results. This study showed challenges with introducing a novel technology as standard of care, with non-compliance mostly driven by one of the sites. No firm conclusions should be drawn regarding the effectiveness of Prevena, as this vanguard trial was not powered for clinical outcomes.

Indexed as

Cardiac Surgical ProceduresSurgical Wound InfectionAgedAnti-Bacterial AgentsAntibiotic ProphylaxisCefazolinCross-Over StudiesFemaleHumansMaleMiddle AgedNegative-Pressure Wound TherapyOntarioPilot ProjectsVancomycinAnti-Bacterial AgentsCefazolinVancomycin

Identifiers

PMID41397003
PMCPMC12704892

What Socratic holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.