Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections

Phase 4

• Conditions: Catheterization; Infection

• Registration Number: NCT01142934
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-01
• Primary Completion: 2012-04
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age ≥ 18 years
• Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings
• 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

• Age < 18 years
• Inability to obtain an informed consent
• Actual evidence - or recent history (< 30 days) - of bloodstream infection
• Central lines inserted in the femoral vein
• Central lines inserted by surgical cutdown
• 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
• Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine
• Any form of dermatitis, burns, skin lesions or tattoos at the insertion site
• Burns over ≥ 15% of the body surface area
• Use of topical antibiotics within a 10cm of the catheter insertion site
• Enrollment in another investigational drug or device study at any time during this study or 30 days prior.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (8)

I.C.U. Ospedale Civico; 🇮🇹 Palermo, PA, Italy

Dpt. Infectious Diseases, Rome Catholic University; 🇮🇹 Rome, RM, Italy

I.C.U. Rome Catholic University; 🇮🇹 Rome, RM, Italy

General Surgery Policlinico Umberto I; 🇮🇹 Rome, RM, Italy

I.C.U. Heart Surgery Policlinico Umberto I; 🇮🇹 Rome, RM, Italy

I.C.U. Neurosurgery Policlinico Umberto I; 🇮🇹 Rome, RM, Italy

I.C.U. Policlinico Umberto I; 🇮🇹 Rome, RM, Italy

Palliative Car Unit - Ospedale di Circolo; 🇮🇹 Varese, VA, Italy