protocolSection identificationModule nctId: NCT06338163, orgStudyIdInfo id: POSSIBLE 1.6, briefTitle: Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery, acronym: POSSIBLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Marco Catarci, class: OTHER, collaborators name: Associazione Chirurghi Ospedalieri Italiani, descriptionModule briefSummary: This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center., conditionsModule conditions: Surgical Site Infection, conditions: Surgical Procedures, Operative, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled prospective multicenter, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessor of the primary outcome will be masked concerning arm allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Polihexanide-based bundle, interventions name: Standard bundle, outcomesModule primaryOutcomes measure: Surgical Site Infections rate, primaryOutcomes measure: Incisional (superficial and deep) Surgical Site Infections rate, primaryOutcomes measure: Infectious morbidity rates, secondaryOutcomes measure: Anastomotic leakage rates, secondaryOutcomes measure: Overall morbidity rates, secondaryOutcomes measure: Major morbidity rates, secondaryOutcomes measure: Comprehensive complication index, secondaryOutcomes measure: Overall length of postoperative hospital stay, secondaryOutcomes measure: Readmission rates, otherOutcomes measure: Patient-reported outcome measures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OSpedale Santa Maria Annunziata, city: Firenze, state: FI, zip: 50012, country: Italy, contacts name: Marco Scatizzi, MD, role: CONTACT, phone: 393474137246, email: marcoscatizzi@gmail.com, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Civile di Macerata, city: Macerata, state: MC, zip: 62100, country: Italy, contacts name: Massimo Sartelli, MD, role: CONTACT, phone: +393405369701, email: massimosartelli@gmail.com, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Ospedale Sandro Pertini, city: Roma, state: RM, zip: 00157, country: Italy, contacts name: Marco Catarci, MD, role: CONTACT, phone: +393298610040, email: marco.catarci@aslroma2.it, contacts name: Michele Benedetti, MD, role: SUB_INVESTIGATOR, contacts name: Paolo Ciano, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False