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

NCT01142934 | Unknown Phase 4 DMC

• 1 other identifier: TegaCHGit01
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 8

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.

Conditions

Catheterization; Infection

Keywords

Catheter-related bloodstream infections; Chlorhexidine; Transparent dressings

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Incidence of adverse events

  Up to 2 days after catheter removal

Study Arms (1)

TegaDerm CHG

OTHER

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)

Interventions

Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG) DEVICE

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.

Also known as: TegaDerm CHG

TegaDerm CHG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• 3M: collaborator
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (8)

I.C.U. Ospedale Civico

Palermo, PA, Italy

RECRUITING

Dpt. Infectious Diseases, Rome Catholic University

Rome, RM, 00168, Italy

RECRUITING

I.C.U. Rome Catholic University

Rome, RM, 00168, Italy

RECRUITING

General Surgery Policlinico Umberto I

Rome, RM, Italy

RECRUITING

I.C.U. Heart Surgery Policlinico Umberto I

Rome, RM, Italy

RECRUITING

I.C.U. Neurosurgery Policlinico Umberto I

Rome, RM, Italy

RECRUITING

I.C.U. Policlinico Umberto I

Rome, RM, Italy

RECRUITING

Palliative Car Unit - Ospedale di Circolo

Varese, VA, Italy

RECRUITING

Related Links

• Related Info
• Italian Group for the Study of Medium and Long Term Vascular Access

MeSH Terms

Conditions

Infections

Study Officials

• Giancarlo Scoppettuolo, MD

  Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)

  PRINCIPAL INVESTIGATOR

• Mauro Pittiruti, MD

  Dpt. Surgery, Rome Catholic University (CUSacredHeart)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Scoppettuolo, MD

CONTACT

+393498380576; g.scoppettuolo@rm.unicatt.it

Mauro Pittiruti, MD

CONTACT

+393388514032; mauro.pittiruti@rm.unicatt.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 14, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

IT (8)