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

Condition(s) studied

Investigational drug(s) / intervention(s)

Application of Prontosan Wound Gel X: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Occurrence of Superficial Surgical Site Infection (SSI) — From the day of surgery until hospital discharge, assessed for up to 30 days.
  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.

Trial sites (1)

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