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

Infection Clinical Trial

— TegaCHG  

Official title:

A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01142934
• Other study ID #: TegaCHGit01
• Status: Recruiting
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: January 31, 2012
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: January 2012
• Source: Catholic University of the Sacred Heart
• Contact: Giancarlo Scoppettuolo, MD
• Phone: +393498380576
• Email: g.scoppettuolo[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheterization
• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
Italy	I.C.U. Ospedale Civico	Palermo	PA
Italy	Dpt. Infectious Diseases, 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	I.C.U. Rome Catholic University	Rome	RM
Italy	Palliative Car Unit - Ospedale di Circolo	Varese	VA

Sponsors (3)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	3M, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter-related bloodstream infection	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)	Up to 7 days after catheter removal	No
Secondary	Incidence of adverse events	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.	Up to 2 days after catheter removal	Yes

External Links

•   Link
•   European Vascular Access Network
•   Italian Group for the Study of Medium and Long Term Vascular Access
•   Rome Catholic University, School of Medicine