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Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac Surgery

Recruitingn/aAges 18 Years - anyAllIRCCS Policlinico S. Donato
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In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the effects of Prontosan® Wound Gel X on the incidence of superficial surgical site infections (SSI) in adult patients undergoing elective cardiac surgery with median sternotomy. The primary objective is to assess how the intraoperative application of the gel impacts the occurrence of SSIs, defined according to CDC/NHSN criteria. Secondary objectives include evaluating the length of hospital stay, the incidence of unplanned re-operations, and identifying any latent clinical subgroups through clustering analysis. The study will be conducted as a prospective, single-center, observational, post-market trial. The primary endpoint will be the incidence of SSIs during the post-operative hospitalization period, while secondary endpoints will focus on hospital stay duration, re-operation rates, and feasibility indicators such as adherence to the protocol and complete

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery) * Ability to provide informed consent * Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment Exclusion Criteria: * Urgent or emergency surgery * Concurrent enrollment in interventional clinical trials * Known hypersensitivity to components of Prontosan Wound Gel X * Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products
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What it tests

  • Application of Prontosan Wound Gel X
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Where

1 site
IRCCS Policlinico San Donato
San Donato Milanese, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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