Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01142934
Study type	Interventional
Source	Catholic University of the Sacred Heart
Contact	Giancarlo Scoppettuolo, MD
Phone	+393498380576
Email	g.scoppettuolo@rm.unicatt.it
Status	Recruiting
Phase	Phase 4
Start date	October 2009
Completion date	October 2012

View Details

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
Terminated	`NCT01441206` - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants	Phase 1
Completed	`NCT01434797` - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed	`NCT01159834` - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms