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

ConditionSurgical Site Infection After Major Surgery

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS Policlinico S. Donato

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

456 Participants

are divided into 1 treatment group

Group A: Single Cohort: Prontosan Wound Gel X Application Group1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Length of Hospital Stay

Defined as the number of days from the date of surgery to the date of hospital discharge. Serves as an indirect marker of postoperative recovery and may reflect complications such as SSIs or delayed healing.

Time frame

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

Incidence of Re-do Surgery

Defined as any unplanned return to the operating room for surgical re-intervention during the same hospitalization, including procedures indicated for SSI, bleeding, mechanical failure, or other clinically relevant reasons.

Time frame

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

Protocol Adherence

Proportion of surgeries in which Prontosan Wound Gel X was applied according to the standardized protocol (correct timing and technique).

Time frame

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

Data Completeness

Percentage of required study fields fully completed in the electronic case report forms.

Time frame

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

Other outcomes

Identification of Latent Clinical Subgroups

Unsupervised hierarchical clustering (Ward's method, Euclidean distance), supported by t-SNE dimensionality reduction, will be used to identify naturally occurring patient subgroups based on demographic, clinical, and procedural variables. Cluster characteristics and associated postoperative outcomes (SSI, length of stay, re-do surgery) will be described for hypothesis generation.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Policlinico S. Donato

Lead sponsor

B. Braun Milano SpA

Collaborator

Source ClinicalTrials.gov

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