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

NCT07275307 | Not Yet Recruiting DMC

• 1 other identifier: CET 315-2025
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

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 completeness of data collection. The study also includes an exploratory endpoint where hierarchical clustering will be used to identify clinical subgroups based on demographic, clinical, and procedural variables. Up to 456 adult patients will be enrolled, all of whom are undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato. The inclusion criteria include patients aged 18 or older, scheduled for surgery, and able to provide informed consent, with the clinical decision to use Prontosan® Wound Gel X during the surgery. Exclusion criteria involve urgent surgeries, participation in other interventional studies, known hypersensitivity to the gel components, or existing skin conditions incompatible with its use. The study duration is estimated to be approximately 18 months, depending on patient enrollment and discharge rates. The follow-up will align with the hospital stay, from the surgery date to discharge, with no post-discharge follow-up planned. Statistical analysis will include a binomial test to compare observed SSI rates with those reported in literature, while secondary data will be analyzed descriptively. An exploratory analysis will use clustering to explore latent clinical subgroups.

Conditions

Surgical Site Infection After Major Surgery

Keywords

Surgical site infection; SSI; Prontosan; Surgery

Outcome Measures

Primary Outcomes (1)

• Occurrence of Superficial Surgical Site Infection (SSI)

  Superficial SSIs are defined according to CDC/NHSN criteria as infections involving only the skin and subcutaneous tissue of the incision, identified by purulent drainage, positive culture from the superficial incision, or clinical signs of infection with deliberate opening by a clinician. Occurrence is assessed through daily postoperative evaluations and confirmed by an independent infectious disease specialist.

  From the day of surgery until hospital discharge, assessed for up to 30 days.

Secondary Outcomes (6)

• Length of Hospital Stay

  From the date of surgery to the date of hospital discharge, assessed for up to 30 days.

• Incidence of Re-do Surgery

  From the date of surgery until hospital discharge, assessed for up to 30 days.

• Protocol Adherence

  From intraoperative period through postoperative hospitalization until discharge, assessed for up to 30 days.

• Data Completeness

  Assessed from the intraoperative period through discharge, for up to 30 days.

• Acceptability of Gel Use

  From intraoperative period through postoperative hospitalization until discharge, for up to 30 days.

Other Outcomes (1)

• Identification of Latent Clinical Subgroups

  From the day of surgery until hospital discharge, with analysis performed after completion of data collection; assessed for up to 30 days.

Study Arms (1)

Single Cohort: Prontosan Wound Gel X Application Group

This is a single-arm, post-marketing cohort including all adult patients (≥18 years) undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato. All enrolled participants receive the intraoperative application of Prontosan Wound Gel X, a polyhexanide-based topical antiseptic gel applied once, immediately after skin closure and before dressing placement, following a standardized, real-world surgical wound management protocol. No randomization or control group is used; all eligible patients receive the same intervention as part of routine clinical practice. The cohort is designed to evaluate the gel's effects on superficial surgical site infection occurrence, alongside secondary outcomes including length of stay, re-do surgeries, and feasibility indicators.

Device: Application of Prontosan Wound Gel X

Interventions

Application of Prontosan Wound Gel X DEVICE

The intervention consists of the intraoperative application of Prontosan Wound Gel X, a polyhexanide-based topical antiseptic gel, applied once immediately after skin closure and before dressing placement during elective cardiac surgery. This procedure follows a standardized surgical wound management protocol as part of routine clinical practice.

Single Cohort: Prontosan Wound Gel X Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato, a high-volume cardiovascular center performing over 1,000 adult cardiac surgeries annually. Eligible participants are consecutively enrolled and represent typical real-world cardiac surgery patients undergoing procedures such as coronary artery bypass grafting, valve repair or replacement, or aortic surgery. All participants receive the intraoperative application of Prontosan Wound Gel X as part of standard wound management. The population excludes patients undergoing urgent or emergency procedures, those with contraindications to the gel, or those enrolled in interventional trials.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• B. Braun Milano SpA: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (21)

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MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Castiello, MSc, RN

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Castiello, MSc, RN

CONTACT

+39 02 5277 4236; gianluca.castiello@grupposandonato.it

Giacomo Bortolussi, MD

CONTACT

+39 02 5277 4236; giacomo.bortolussi@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)