Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT01142934
Status:
UNKNOWN
Last Update Posted:
2012-02-01
First Post:
2010-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of catheter-related bloodstream infection', 'timeFrame': 'Up to 7 days after catheter removal', 'description': 'According to the definition of CRBSI suggested in "Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of America" (Clin Infect Dis 2009; 49:1-45)'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 2 days after catheter removal', 'description': 'Other Secondary Outcome Measures are represented by: determining whether TegadermTM CHG decreases catheter colonization; determining whether TegadermTM CHG decreases the incidence of catheter site infection; evaluating patient comfort; to evaluate overall nursing satisfaction (ease of dressing application, incidence of dressing edge lift, ability to visualize the catheter insertion site, ease of removal); determining whether TegadermTM CHG decreases the incidence of unscheduled dressing change compared to the control group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Catheter-related bloodstream infections', 'Chlorhexidine', 'Transparent dressings'], 'conditions': ['Catheterization', 'Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.3m.com/', 'label': 'Related Info'}, {'url': 'http://www.gavecelt.info', 'label': 'Italian Group for the Study of Medium and Long Term Vascular Access'}]}, 'descriptionModule': {'briefSummary': 'TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The primary endpoint is the occurrence of CRBSI and the secondary endpoints are:\n\ncatheter colonization (growth of microbes from the culture of catheter tip, \\> 15 CFU according to semi-quantitative method or \\> 1000 CFU according to quantitative method); incidence of catheter exit site infection; occurrence of catheter related infections/sepsis or other severe infection-related complications; safety profile evaluation: occurrence of hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other) or on that of patient symptoms (itch, burning sensation); relating to the device performance: incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion site, easiness of removal, easiness of dressing application; incidence of unscheduled dressing change. The study hypothesis implies that the use of slow release device containing chlorhexidine may decrease the incidence of CRBSI. This has already been showed for chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication is directly released by an integrated transparent gel pad, so that the catheter exit site remains visible and easy to inspect without removing the dressing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings\n* Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Inability to obtain an informed consent\n* Actual evidence - or recent history (\\< 30 days) - of bloodstream infection\n* Central lines inserted in the femoral vein\n* Central lines inserted by surgical cutdown\n* Use of so called 'treated' catheters, i.e. catheters whose internal and/or external surface is coated with antibacterial drugs as well as catheters whose polyurethane releases ions with potential antiseptic action, should be excluded by the present protocol\n* Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine\n* Any form of dermatitis, burns, skin lesions or tattoos at the insertion site\n* Burns over ≥ 15% of the body surface area\n* Use of topical antibiotics within a 10cm of the catheter insertion site\n* Enrollment in another investigational drug or device study at any time during this study or 30 days prior."}, 'identificationModule': {'nctId': 'NCT01142934', 'acronym': 'TegaCHG', 'briefTitle': 'Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS', 'orgStudyIdInfo': {'id': 'TegaCHGit01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TegaDerm CHG', 'description': 'TegaDerm CHG is the interventional arm to be compared with the control group in which the dressing is TegaDerm (without CHG).', 'interventionNames': ['Device: Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)']}], 'interventions': [{'name': 'Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)', 'type': 'DEVICE', 'otherNames': ['TegaDerm CHG'], 'description': 'The intervention is represented by the combination of the TegaDerm transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity.', 'armGroupLabels': ['TegaDerm CHG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Palermo', 'state': 'PA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Zina Picciuca, RN', 'role': 'CONTACT', 'email': 'zina@ospedalecivicopa.org'}, {'name': 'Zina Picciuca, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.C.U. Ospedale Civico', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00168', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giancarlo Scoppettuolo, MD', 'role': 'CONTACT', 'email': 'g.scoppettuolo@rm.unicatt.it', 'phone': '+393498380576'}, {'name': 'Laura Dolcetti, RN', 'role': 'CONTACT', 'email': 'laura.dolcetti@libero.it', 'phone': '+393336157080'}, {'name': 'Laura Dolcetti, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giancarlo Scoppettuolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dpt. Infectious Diseases, Rome Catholic University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Mencio, RN', 'role': 'CONTACT', 'email': 'vincenzomencio@interfree.it'}, {'name': 'Vincenzo Mencio, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.C.U. Rome Catholic University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Susanna Sodo, RN', 'role': 'CONTACT', 'email': 's.sodo@policlinicoumberto1.it'}, {'name': 'Susanna Sodo, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Surgery Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Susanna Sodo, RN', 'role': 'CONTACT', 'email': 's.sodo@policlinicoumberto1.it'}, {'name': 'Susanna Sodo, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.C.U. Heart Surgery Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Susanna Sodo, RN', 'role': 'CONTACT', 'email': 's.sodo@policlinicoumberto1.it'}, {'name': 'Susanna Sodo, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.C.U. Neurosurgery Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Susanna Sodo, RN', 'role': 'CONTACT', 'email': 's.sodo@policlinicoumberto1.it'}], 'facility': 'I.C.U. Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Varese', 'state': 'VA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Bertollo, MD', 'role': 'CONTACT', 'email': 'dani.fabi@tin.it'}, {'name': 'Daniele Bertollo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Palliative Car Unit - Ospedale di Circolo', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Giancarlo Scoppettuolo, MD', 'role': 'CONTACT', 'email': 'g.scoppettuolo@rm.unicatt.it', 'phone': '+393498380576'}, {'name': 'Mauro Pittiruti, MD', 'role': 'CONTACT', 'email': 'mauro.pittiruti@rm.unicatt.it', 'phone': '+393388514032'}], 'overallOfficials': [{'name': 'Giancarlo Scoppettuolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)'}, {'name': 'Mauro Pittiruti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dpt. Surgery, Rome Catholic University (CUSacredHeart)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}, {'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giancarlo Scoppettuolo', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}