Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue Health Condition 2: L00-L08- Infections of the skin and subcutaneous tissue Health Condition 3: L08- Other local infections of skin andsubcutaneous tissue Health Condition 4: L08- Other local infections of skin andsubcutaneous tissue
Conditions
Interventions
Intervention1: VELFIX® EDGE plus CHG: Cannula securement patch dressing.
Control Intervention1: N/Ap: N/Ap
Sponsors
Datt Mediproducts Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female in the Age group of 18 to 70 years both included. 2.Hospitalized, ICU and Non-ICU patients. 3.Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC 4.Patients catheterized for, Central venous Dialysis, Broviac catheters, Epidural, Arterial, Peripheral/Midline venous catheters/ cannula that shall stay for a minimum duration of 96 hours. 5.Include femoral vein catheter insertion patients.
Exclusion criteria
Exclusion criteria: 1.Age 2.Inability to obtain an informed consent. 3.Actual evidence - or recent history ( 4.Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine. 5.Patients with critical illness vital organ dysfunction 6.Threatened airway 7.All respiratory arrests 8.Respiratory rate ?40 or ?8 breaths/min 9.Oxygen saturation 10.All cardiac arrests 11.Pulse rate 140 beats/min 12.Systolic blood pressure 13.Sudden fall in level of consciousness (fall in Glasgow coma score >2 points) 14.Repeated or prolonged seizures 15.Rising arterial carbon dioxide tension with respiratory acidosis 16.Any patient giving cause for concern 17.Use of anti-bacterial treated catheters, i.e., catheters coated with antibacterial drugs as well as catheters whose polyurethane releases ions with potential antiseptic action. 18.Any form of dermatitis, burns, skin lesions or tattoos at the insertion site. 19.Use of topical antibiotics within a 10cm of the catheter insertion site. 20.Enrolment in another investigational drug or device study at any time during this study or 30 days prior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of colonized of microorganisms Through a Swab test at the Catheter Patch Insertion SiteTimepoint: Up-to 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Study participants having hypersensitivity to VELFIX® EDGE plus CHG cannula securement patch dressing. Study participants having dermatitis at the site of catheter insertion. Study participants with no skin tissue adhesives to secure peripheral intravenous catheters.Timepoint: During the course of the study (within 7 days of application) | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Pvt. Ltd.
Outcome results
None listed