CTRI/2025/11/097777招募中Unknown
A Post-Marketing study, Randomized, Multicentric Clinical Study to Assess the Safety and Efficacy of an IV securement dressing, VELFIX EDGE Plus CHG in comparison to TegadermTM CHG in Reducing Catheter-Related Bloodstream Infections. (CRBSIs)
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 2
研究概览
简要总结
VELFIX Ede+ CHG and Tegaderm CHG are chlorhexidine-impregnated IV securement dressings designed to stabilize catheters and provide continuous antimicrobial protection. By reducing skin flora at the insertion site and minimizing catheter movement, both significantly lower the risk of catheter-related bloodstream infections in clinical use.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Dr Ajeet Singh Chahar
S.N Medical College
研究点 (2)
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