Health Condition 1: D75- Other and unspecified diseases ofblood and blood-forming organs
Conditions
Interventions
Intervention1: VELFIX EDGE + CHG: IV securement dressing
Total duration would be 7 days post device application.
Control Intervention1: Tegaderm CHG: IV securement dressing.
Total duration would be 7
Sponsors
Datt Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 to 75 years, of any gender. Hospitalized patients in either Intensive Care Units or general wards. Require short-term vascular catheterization expected to remain in place for a duration of 7 days. Able and willing to provide written informed consent, either personally or via a legally authorized representative (LAR). Agree to allow study data collection according to protocol-defined time points.
Exclusion criteria
Exclusion criteria: Age below 18 years or above 75 years. Known or suspected hypersensitivity to chlorhexidine, transparent dressings, or adhesive components. Presence of dermatitis, burns, skin lesions, or tattoos at or near the intended catheter insertion site. Any history of bloodstream infection within the preceding 30 days. Central lines inserted in the femoral vein or via a surgical cut-down technique. Use of antibacterial-coated or antiseptic-releasing catheters, including polyurethane catheters designed to release ions or antimicrobial agents. Use of topical antibiotics within a 10 cm radius of the insertion site. Extensive burns covering 15% or more of total body surface area. Current therapy with immune-system modulators (e.g., corticosteroids, biologics, immunosuppressants). Participation in another investigational drug or device study during the study or within 30 days prior to screening. Pregnant females. Inability or unwillingness to provide informed consent, either personally or via LAR A Positive HIV test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative incidence of Catheter-Related Bloodstream Infection (CRBSI) within 7 days of catheter insertion between VELFIX EDGE + CHG and Tegaderm CHG, confirmed by blood culture at baseline (day 0), and day 7Timepoint: 7 days from device application | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative incidence of local skin reactions, dermatitis, or allergic reactions at the catheter insertion site associated with VELFIX EDGE + CHG versus Tegaderm CHG. Comparative microbial colonization at the catheter insertion site, assessed by swab test, with significant colonization defined as more than or equal to 10 CFU per mL for each dressing type. Investigator-reported satisfaction and usability comparison between VELFIX EDGE + CHG and Tegaderm CHG. Comparative device adherence and integrity, including incidence of dressings becoming loose or detached. Overall safety comparison, including adverse events (AEs) related to each device. Timepoint: 7 days from device application | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Pvt Ltd
Outcome results
None listed