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

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ClinicalTrials.gov Identifier: NCT01142934
Recruitment Status : Unknown
Verified January 2012 by Giancarlo Scoppettuolo, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : June 14, 2010
Last Update Posted : February 1, 2012
Sponsor:
Collaborators:
3M
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by (Responsible Party):
Giancarlo Scoppettuolo, 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.


Condition or disease Intervention/treatment Phase
Catheterization Infection Device: Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS
Study Start Date : October 2009
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : October 2012


Arm Intervention/treatment
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 Name: TegaDerm CHG




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142934


Contacts
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Contact: Giancarlo Scoppettuolo, MD +393498380576 g.scoppettuolo@rm.unicatt.it
Contact: Mauro Pittiruti, MD +393388514032 mauro.pittiruti@rm.unicatt.it

Locations
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Italy
I.C.U. Ospedale Civico Recruiting
Palermo, PA, Italy
Contact: Zina Picciuca, RN       zina@ospedalecivicopa.org   
Principal Investigator: Zina Picciuca, RN         
Dpt. Infectious Diseases, Rome Catholic University Recruiting
Rome, RM, Italy, 00168
Contact: Giancarlo Scoppettuolo, MD    +393498380576    g.scoppettuolo@rm.unicatt.it   
Contact: Laura Dolcetti, RN    +393336157080    laura.dolcetti@libero.it   
Sub-Investigator: Laura Dolcetti, RN         
Principal Investigator: Giancarlo Scoppettuolo, MD         
I.C.U. Rome Catholic University Recruiting
Rome, RM, Italy, 00168
Contact: Vincenzo Mencio, RN       vincenzomencio@interfree.it   
Principal Investigator: Vincenzo Mencio, RN         
General Surgery Policlinico Umberto I Recruiting
Rome, RM, Italy
Contact: Susanna Sodo, RN       s.sodo@policlinicoumberto1.it   
Principal Investigator: Susanna Sodo, RN         
I.C.U. Heart Surgery Policlinico Umberto I Recruiting
Rome, RM, Italy
Contact: Susanna Sodo, RN       s.sodo@policlinicoumberto1.it   
Principal Investigator: Susanna Sodo, RN         
I.C.U. Neurosurgery Policlinico Umberto I Recruiting
Rome, RM, Italy
Contact: Susanna Sodo, RN       s.sodo@policlinicoumberto1.it   
Principal Investigator: Susanna Sodo, RN         
I.C.U. Policlinico Umberto I Recruiting
Rome, RM, Italy
Contact: Susanna Sodo, RN       s.sodo@policlinicoumberto1.it   
Palliative Car Unit - Ospedale di Circolo Recruiting
Varese, VA, Italy
Contact: Daniele Bertollo, MD       dani.fabi@tin.it   
Principal Investigator: Daniele Bertollo, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
3M
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
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Principal Investigator: Giancarlo Scoppettuolo, MD Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)
Principal Investigator: Mauro Pittiruti, MD Dpt. Surgery, Rome Catholic University (CUSacredHeart)

Additional Information:
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Responsible Party: Giancarlo Scoppettuolo, MD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01142934     History of Changes
Other Study ID Numbers: TegaCHGit01
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Giancarlo Scoppettuolo, Catholic University of the Sacred Heart:
Catheter-related bloodstream infections
Chlorhexidine
Transparent dressings

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents