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

January 31, 2012 updated by: Giancarlo Scoppettuolo, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PA
      • Palermo, PA, Italy
        • Recruiting
        • I.C.U. Ospedale Civico
        • Contact:
        • Principal Investigator:
          • Zina Picciuca, RN
    • RM
      • Rome, RM, Italy, 00168
        • Recruiting
        • Dpt. Infectious Diseases, Rome Catholic University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Laura Dolcetti, RN
        • Principal Investigator:
          • Giancarlo Scoppettuolo, MD
      • Rome, RM, Italy, 00168
        • Recruiting
        • I.C.U. Rome Catholic University
        • Contact:
        • Principal Investigator:
          • Vincenzo Mencio, RN
      • Rome, RM, Italy
        • Recruiting
        • General Surgery Policlinico Umberto I
        • Contact:
        • Principal Investigator:
          • Susanna Sodo, RN
      • Rome, RM, Italy
        • Recruiting
        • I.C.U. Heart Surgery Policlinico Umberto I
        • Contact:
        • Principal Investigator:
          • Susanna Sodo, RN
      • Rome, RM, Italy
        • Recruiting
        • I.C.U. Neurosurgery Policlinico Umberto I
        • Contact:
        • Principal Investigator:
          • Susanna Sodo, RN
      • Rome, RM, Italy
    • VA
      • Varese, VA, Italy
        • Recruiting
        • Palliative Car Unit - Ospedale di Circolo
        • Contact:
        • Principal Investigator:
          • Daniele Bertollo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • TegaDerm CHG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of catheter-related bloodstream infection
Time Frame: 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)
Up to 7 days after catheter removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
Up to 2 days after catheter removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TegaCHGit01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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