TegaCHG: Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections
Study Details
Study Description
Brief Summary
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:
catheter 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: TegaDerm CHG TegaDerm CHG is the interventional arm to be compared with the control group in which the dressing is TegaDerm (without CHG). |
Device: Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of catheter-related bloodstream infection [Up to 7 days after catheter removal]
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)
Secondary Outcome Measures
- Incidence of adverse events [Up to 2 days after catheter removal]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
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Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings
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Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC
Exclusion Criteria:
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Age < 18 years
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Inability to obtain an informed consent
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Actual evidence - or recent history (< 30 days) - of bloodstream infection
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Central lines inserted in the femoral vein
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Central lines inserted by surgical cutdown
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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
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Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine
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Any form of dermatitis, burns, skin lesions or tattoos at the insertion site
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Burns over ≥ 15% of the body surface area
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Use of topical antibiotics within a 10cm of the catheter insertion site
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Enrollment in another investigational drug or device study at any time during this study or 30 days prior.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | I.C.U. Ospedale Civico | Palermo | PA | Italy | |
| 2 | Dpt. Infectious Diseases, Rome Catholic University | Rome | RM | Italy | 00168 |
| 3 | I.C.U. Rome Catholic University | Rome | RM | Italy | 00168 |
| 4 | General Surgery Policlinico Umberto I | Rome | RM | Italy | |
| 5 | I.C.U. Heart Surgery Policlinico Umberto I | Rome | RM | Italy | |
| 6 | I.C.U. Neurosurgery Policlinico Umberto I | Rome | RM | Italy | |
| 7 | I.C.U. Policlinico Umberto I | Rome | RM | Italy | |
| 8 | Palliative Car Unit - Ospedale di Circolo | Varese | VA | Italy |
Sponsors and Collaborators
- Catholic University of the Sacred Heart
- 3M
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
- Principal Investigator: Giancarlo Scoppettuolo, MD, Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)
- Principal Investigator: Mauro Pittiruti, MD, Dpt. Surgery, Rome Catholic University (CUSacredHeart)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TegaCHGit01