A post-marketing surveillance study, to check quality, safety and performance of a cannula securement patch dressing (VELFIX® EDGE plus CHG) in reducing catheter Related Bloodstream Infection.
- Conditions
- Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissueHealth Condition 2: L00-L08- Infections of the skin and subcutaneous tissueHealth Condition 3: L08- Other local infections of skin andsubcutaneous tissueHealth Condition 4: L08- Other local infections of skin andsubcutaneous tissue
- Registration Number
- CTRI/2023/04/051786
- Lead Sponsor
- Datt Mediproducts Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
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.
1.Age < 18 years & more than 70 yrs.
2.Inability to obtain an informed consent.
3.Actual evidence - or recent history ( < 30 days) - of bloodstream infection.
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 <90% on ?50% oxygen
10.All cardiac arrests
11.Pulse rate <40 or >140 beats/min
12.Systolic blood pressure <90 mm Hg
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of colonized of microorganisms Through a Swab test at the Catheter Patch <br/ ><br>Insertion SiteTimepoint: Up-to 7 days
- Secondary Outcome Measures
Name Time Method Study participants having hypersensitivity to VELFIX® EDGE plus CHG cannula securement patch dressing. <br/ ><br>Study participants having dermatitis at the site of catheter insertion. <br/ ><br>Study participants with no skin tissue adhesives to secure peripheral intravenous catheters.Timepoint: During the course of the study (within 7 days of application)