Status:
UNKNOWN
Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
3M
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Conditions:
Catheterization
Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01142934
Start Date
October 1 2009
End Date
October 1 2012
Last Update
February 1 2012
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
I.C.U. Ospedale Civico
Palermo, PA, Italy
2
Dpt. Infectious Diseases, Rome Catholic University
Rome, RM, Italy, 00168
3
I.C.U. Rome Catholic University
Rome, RM, Italy, 00168
4
General Surgery Policlinico Umberto I
Rome, RM, Italy