CTRI/2023/04/051786CompletedUnknown
A post-marketing surveillance multi-centric study to evaluate quality, safety and performance of VELFIX® EDGE plus CHG a cannula securement patch dressing in Reducing catheter Related Bloodstream Infection.
Datt Mediproducts Pvt. Ltd.2 sites in 1 country300 target enrollmentStarted: April 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Datt Mediproducts Pvt. Ltd.
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Detection of colonized of microorganisms Through a Swab test at the Catheter Patch
Study Overview
Brief Summary
It comprises a transparent adhesive dressing to act as a barrier against external contamination and an integrated gel pad containing an antiseptic agent. VELFIX® EDGE + CHG cannula securement dressing is associated with lower incidence of catheter related infection, and reduction in dermatitis incidence, related to the application of VELFIX® EDGE + CHG cannula securement dressing.
300 Subjects will be enrolled.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
Detection of colonized of microorganisms Through a Swab test at the Catheter Patch
Time Frame: Up-to 7 days
Insertion Site
Time Frame: Up-to 7 days
Secondary Outcomes
- Study participants having hypersensitivity to VELFIX® EDGE plus CHG cannula securement patch dressing.(Study participants having dermatitis at the site of catheter insertion.)
Investigators
Study Sites (2)
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