Prontosan Wound Gel X in heart surgery shows whether it lowers surgical site infections
Official title: Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study
Run by IRCCS Policlinico S. Donato · NCT07275307 · Data updated 2026-11-12
This study tests if applying Prontosan Wound Gel X during elective heart surgery can lower superficial surgical site infections in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 456 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Michigan) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07275307 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults planned for elective cardiac surgery with median sternotomy where the treating surgeon plans to apply Prontosan Wound Gel X.
✕Probably not a fit
Patients whose wounds do not develop SSIs or who do not receive the gel due to surgeon decision or contraindications may not derive a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, observational study evaluating the intraoperative use of Prontosan Wound Gel X in adults undergoing elective cardiac surgery with median sternotomy. The primary outcome is the rate of superficial surgical site infections during the post-operative hospital stay, defined by CDC/NHSN criteria. Secondary outcomes include length of stay, unplanned re-operations, data-adherence, and data completeness, with exploratory clustering to identify distinct patient subgroups. The study is post-market and uses routine clinical practice to assess real-world feasibility and potential benefits. It does not involve randomization or an interventional control arm.
Why it matters
Potential benefit: If successful, the approach could reduce superficial SSIs and shorten hospital stays for patients undergoing cardiac surgery.
How similar studies have gone: Prior observational work suggests antiseptic wound-care products can impact SSI rates, but this specific gel in this surgical setting is being evaluated in a real-world context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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IRCCS Policlinico San Donato
San Donato Milanese, Michigan, Italy Recruiting
Study contacts
- Principal investigator: Gianluca Castiello, MSc, RN — IRCCS Policlinico S. Donato
- Study coordinator: Gianluca Castiello, MSc, RN
- Email: gianluca.castiello@grupposandonato.it
- Phone: +39 02 5277 4236
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perioperative oxygen comparison for adults having major surgery
This will test whether giving higher (80%), medium (50%), or lower (≤30%) oxygen during and right after major surgery changes wound infection rates and recovery for adults having longer operations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.