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CTRI Number  CTRI/2025/11/097777 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the safety and effectiveness of two IV securement dressings, Velfix Edge Plus CHG and Tegaderm™ CHG — in preventing bloodstream infections related to catheters. 
Scientific Title of Study   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) 
Trial Acronym  CRBSIs 
Secondary IDs if Any  
Secondary ID  Identifier 
DMPL/CIP-008-2025/CT/VF, Version 1.0, dated, 10-Oct-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajeet Singh Chahar 
Designation  Associate Professor 
Affiliation  S.N Medical College 
Address  Department of Medicine, S.N Medical College, Agra, Uttar Pradesh - 282003

Agra
UTTAR PRADESH
282003
India 
Phone  8923414151  
Fax    
Email  drajeetchahar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth Pandey 
Designation  Vice president & Head R and D 
Affiliation  Datt Mediproducts Pvt Ltd 
Address  Datt Mediproducts Pvt. Ltd. 56, Community Center, East of Kailash, New Delhi, 110065, India

South
DELHI
110065
India 
Phone  9315829298  
Fax    
Email  siddharth.pandey@dattmedi.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Bablani 
Designation  GM Clinical Research Operations 
Affiliation  Datt Mediproducts Pvt Ltd 
Address  Datt Mediproducts Pvt. Ltd. 56, Community Center, East of Kailash, New Delhi, 110065, India

South
DELHI
110065
India 
Phone  09315785417  
Fax    
Email  pankaj.bablani@dattmedi.com  
 
Source of Monetary or Material Support  
Sponsor 
 
Primary Sponsor  
Name  Datt Mediproducts Pvt Ltd 
Address  56, Community Centre, East of Kailash, New Delhi, India - 110065 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nutan Kumar Agrawal  MLB Medical College,   Kanpur Road, Jhansi Uttar Pradesh
Jhansi
UTTAR PRADESH 		 9839789378

dr_nutan_agrawal@yahoo.com 
Dr Ajeet Singh Chahar  S.N Medical College  S.N Medical College, Agra, Uttar Pradesh
Agra
UTTAR PRADESH 		 8923414151

drajeetchahar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee S.N Medical College, Agra  Approved 
INSTITUTIONAL ETHICS COMMITTEE, MLB, Jhansi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D75||Other and unspecified diseases ofblood and blood-forming organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tegaderm CHG  IV securement dressing. Total duration would be 7 days post device application. 
Intervention  VELFIX EDGE + CHG  IV securement dressing Total duration would be 7 days post device application. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 7  7 days from device application 
 
Secondary Outcome  
Outcome  TimePoints 
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 10³ 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.
 		 7 days from device application 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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