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.0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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.

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