| CTRI Number |
CTRI/2023/04/051786 [Registered on: 19/04/2023] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A post-marketing surveillance study, to check quality, safety and performance of a cannula securement patch dressing (VELFIX® EDGE plus CHG) in reducing catheter Related Bloodstream Infection. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DMPL/CIP-008-2022/CT/VEC Version 2.0; 25 May-2023 |
Protocol Number |
| DMPL/CIP-008-2022/CT/VEC, version 1.0, 01-Feb-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Soni |
| Designation |
Professor & HOD, Dept. of General Medicine |
| Affiliation |
Professor, Dept. of General Medicine, PCMCs PGI & YCM hospital |
| Address |
PCMCs PGI & YCM Hospital,
Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822057511 |
| Fax |
|
| Email |
drpravinsoni18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vise President and R & D Head |
| Affiliation |
Datt Mediproducts Pvt. Ltd. |
| Address |
Datt Mediproducts Pvt. Ltd.
52-54,63 & 64, Roz Ka Meo Industrial
Area Nuh, Distt. Mewat (Haryana)-India
Gurgaon
HARYANA
122103
India |
| Phone |
|
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
General Manager Clinical Research |
| Affiliation |
Datt Mediproducts Pvt. Ltd. |
| Address |
Datt Mediproducts Pvt. Ltd.
56, Community Centre, East of Kailash,
New Delhi, India - 110065
South
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt Mediproducts Pvt. Ltd |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajat Kapoor |
S.N Medical college, Agra |
S.N Medical College, Agra, Near Agra College, Central Library Agra -282003
Agra
UTTAR PRADESH |
8958931243
rajatsarvkapoor@gmail.com |
| Dr Pravin Soni |
Yashwantrao Chavan Memorial Hospital |
PCMCs PGI & YCM Hospital, Pimpri, Pune
Pune
MAHARASHTRA |
9822057511
drpravinsoni18@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE S. N. Medical College Agra |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, (2) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, (3) ICD-10 Condition: L08||Other local infections of skin andsubcutaneous tissue, (4) ICD-10 Condition: L08||Other local infections of skin andsubcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/Ap |
N/Ap |
| Intervention |
VELFIX® EDGE plus CHG |
Cannula securement patch dressing. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Detection of colonized of microorganisms Through a Swab test at the Catheter Patch
Insertion Site |
Up-to 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study participants having hypersensitivity to VELFIX® EDGE plus CHG cannula securement patch dressing.
Study participants having dermatitis at the site of catheter insertion.
Study participants with no skin tissue adhesives to secure peripheral intravenous catheters. |
During the course of the study (within 7 days of application) |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
05/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |