Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01142934
Other study ID # TegaCHGit01
Secondary ID
Status Recruiting
Phase Phase 4
First received May 24, 2010
Last updated January 31, 2012
Start date October 2009
Est. completion date October 2012

Study information

Verified date January 2012
Source Catholic University of the Sacred Heart
Contact Giancarlo Scoppettuolo, MD
Phone +393498380576
Email g.scoppettuolo@rm.unicatt.it
Is FDA regulated No
Health authority Italy: Ethics CommitteeItaly: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date October 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy I.C.U. Ospedale Civico Palermo PA
Italy Dpt. Infectious Diseases, Rome Catholic University Rome RM
Italy General Surgery Policlinico Umberto I Rome RM
Italy I.C.U. Heart Surgery Policlinico Umberto I Rome RM
Italy I.C.U. Neurosurgery Policlinico Umberto I Rome RM
Italy I.C.U. Policlinico Umberto I Rome RM
Italy I.C.U. Rome Catholic University Rome RM
Italy Palliative Car Unit - Ospedale di Circolo Varese VA

Sponsors (3)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart 3M, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Incidence of adverse events 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 Yes
See also
  Status Clinical Trial Phase
Completed NCT04529421 - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting NCT00342589 - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Withdrawn NCT04217252 - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection N/A
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Withdrawn NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting NCT02768454 - Antimicrobials Stewardship by Pharmacist N/A
Completed NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery N/A
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Recruiting NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts N/A
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Completed NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Terminated NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants Phase 1
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A