P-394. Prevention Of Infections In Cardiac Surgery (PICS)-Prevena Study – a pilot/vanguard factorial cluster cross-over RCT
Notice bibliographique
Résumé
Abstract Background Sternal surgical site infections (s-SSI) after cardiac surgery can lead to significant morbidity, mortality, and costs. Among cardiac surgery patients, the effects of negative pressure wound management is unknown.Table 1:Baseline CharacteristicsBMI= Body Mass Index; COPD= Chronic obstructive pulmonary disease; CABG= Coronary artery bypass graft; SD= Standard deviation Methods The PICS-PREVENA Vanguard study, a 2x2 factorial, open label, cluster-randomized crossover trial, was conducted at 2 hospitals in Ontario, Canada (NCT03402945). We randomized each site to one of four sequences of the four study arms – each arm combining either cefazolin mono vs. combination prophylaxis with vancomycin (not analyzed) with either standard wound dressing vs. the 3M Prevena incision management system (Prevena). Only diabetic or obese patients (BMI >30kg/m2) were eligible for the latter comparison. For this population, we report the feasibility and efficacy endpoints of the Prevena versus standard wound dressing interventions. Feasability was assessed by adherence to the study protocol and loss to follow-up. The primary efficacy outcome was a composite of deep and organ-space s-SSI within 90-days after surgery. We used mixed logistic regression, accounting for clusters as a random effect for analysis. Funding: KCI USA, Inc.Table 2:Outcomes at end of follow up (90 days)BMI= Body Mass Index; s-SSI= Sternal surgical site infections; SSI= surgical site infections; ICU= intensive care unit; OR= odds ratio; SD= Standard deviation; CI= confidence interval^ Mean Difference* For patients with open venous saphenous harvest Results Among the 4107 included patients, 2230 were obese or diabetic. Of these patients, 1208 underwent surgery during a standard wound dressing period, and 1022 during a Prevena allocated period (Figure and Table 1). Of the latter, 696 (68.1%) had Prevena applied. Loss to follow up was 3.6% for obese or diabetic patients. Deep and organ-space s-SSI occurred in 16 (1.6%) and 17 (1.4%) in the Prevena and standard wound dressing allocated periods, respectively (OR= 1.11, 95% CI: 0.56- 2.20). Other clinical outcomes (Table 2) did not suggest a difference: all s-SSI (3.8% vs. 3.4%, OR: 1.12, 95% CI: 0.71- 1.75), SSI on legs (0.5% vs. 0.3%, OR: 1.41, 95% CI: 0.38- 5.30), and 90-day mortality (3.8% vs. 4.7%; OR: 0.79 (95% CI: 0.52- 1.20). An on-treatment analysis showed similar results.Figure 1:Treatment assignmentBMI= Body Mass Index Conclusion The vanguard study showed challenges with introducing a novel technology as standard of care with only a 68% compliance overall, with non-compliance mostly driven by one of the sites. No conclusions should be drawn regarding the efficacy of Prevena, as this Vanguard phase was not powered for these outcomes. Disclosures Richard Whitlock, PhD, Abbott: Grant/Research Support|Atricure: Grant/Research Support|CytoSorbents: Grant/Research Support PJ Devereaux, MD, PhD, Abbott Diagnostics: Advisor/Consultant|Abbott Diagnostics: Grant/Research Support|AOP Pharma: Grant/Research Support|Astra Zeneca: Advisor/Consultant|Bayer: Advisor/Consultant|CloudDX: Monitoring Devices|Quidel Canada: Advisor/Consultant|Renibus: Advisor/Consultant|Roche Canada: Advisor/Consultant|Roche Diagnostics: Grant/Research Support|Siemens: Grant/Research Support|Trimedic: Advisor/Consultant Dominik Mertz, MD, MSc, KCI Inc. USA: Grant/Research Support
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».