[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614108":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Cohort: Prontosan Wound Gel X Application Group",null,"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.",[13],"Device: Application of Prontosan Wound Gel X",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","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.",[9],[21],{"name":22,"affiliation":5,"role":23},"Gianluca Castiello, MSc, RN","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+39 02 5277 4236","gianluca.castiello@grupposandonato.it",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"Giacomo Bortolussi, MD","giacomo.bortolussi@grupposandonato.it",[33],{"facility":34,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IRCCS Policlinico San Donato","San Donato Milanese","MI","20097","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],9.26838,45.41047,{"lat":44,"lon":43},[47],{"name":48,"role":26,"phone":27,"phoneExt":10,"email":49},"Mattia Ricotti","mattia.ricotti@grupposandonato.it",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[53],{"name":54,"class":55},"B. Braun Milano SpA","UNKNOWN","100614108","impact-of-prontosan-wound-gel-x-on-surgical-site-infections-in-cardiac-surgery-100614108",false,"NCT07275307","Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac Surgery","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","PRONTOSAN","Inclusion Criteria:\n\n* Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery)\n* Ability to provide informed consent\n* Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment\n\nExclusion Criteria:\n\n* Urgent or emergency surgery\n* Concurrent enrollment in interventional clinical trials\n* Known hypersensitivity to components of Prontosan Wound Gel X\n* Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products","ALL","18 Years",{"count":67,"type":68},456,"ESTIMATED","OBSERVATIONAL","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\u002FNHSN 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.\n\nThe 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.\n\nUp 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.\n\nThe 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.",[72],"Surgical Site Infection After Major Surgery",[74,75,76,77],"Surgical site infection","SSI","Prontosan","Surgery","NOT_YET_RECRUITING","2025-11-27",{"date":81,"type":82},"2025-12-10","ACTUAL",{"date":84,"type":68},"2026-01-08",{"date":86,"type":68},"2027-12",{"name":5,"class":6},1]