Clinical trial NCT01142934: Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections
Official title: A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Catheterization
Infection
Keywords: Catheter-related bloodstream infections
Chlorhexidine
Transparent dressings
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: 3M
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2010-06-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of catheter-related bloodstream infection
timeFrame: Up to 7 days after catheter removal
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 2 days after catheter removal
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: I.C.U. Ospedale Civico
state: PA
city: Rome
country: Italy
facility: Dpt. Infectious Diseases, Rome Catholic University
state: RM
city: Rome
country: Italy
facility: I.C.U. Rome Catholic University
state: RM
city: Rome
country: Italy
facility: General Surgery Policlinico Umberto I
state: RM
city: Rome
country: Italy
facility: I.C.U. Heart Surgery Policlinico Umberto I
state: RM
city: Rome
country: Italy
facility: I.C.U. Neurosurgery Policlinico Umberto I
state: RM
city: Rome
country: Italy
facility: I.C.U. Policlinico Umberto I
state: RM
city: Varese
country: Italy
facility: Palliative Car Unit - Ospedale di Circolo
state: VA
Study officials:
affiliation: Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)
name: Giancarlo Scoppettuolo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt. Surgery, Rome Catholic University (CUSacredHeart)
name: Mauro Pittiruti, MD
role: PRINCIPAL_INVESTIGATOR
References: