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Hoy — Diciembre 16th 2025Tus fuentes RSS

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

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

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

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: 
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Short- and long-term complications after slowly resorbable biosynthetic P4HB mesh (Phasix) implantation in European centres: a protocol paper for a multiregistry study

Por: van den Berg · R. · Wieser · M. · Jeekel · J. · Stabilini · C. · Bueno-Lledo · J. · Köckerling · F. · Chatzimavroudis · G. · Jorgensen · L. N. · Romain · B. · PRS Group (Phasix Research Study Group) · Soliani · Lopez-Cano · Rodriguez · Gillion · Dubuisson · Ortega-Deballon · C
Background

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.

 Methods and analysis

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.

 Ethics and dissemination

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.
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