| CTRI Number |
CTRI/2024/02/063282 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety and effectiveness of a new antimicrobial wound dressing (VELVERT) in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis |
|
Scientific Title of Study
|
An open label, single-centric, non-randomized clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/CIP-001-2024/CT/VV Version: 1.0 Date : 01-Jan-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Kumar |
| Designation |
Prof. & Head Department of Plastic Surgery |
| Affiliation |
Maharani Laxmi Bai Medical College |
| Address |
Room No.01, Dept of Plastic Surgery, Ground floor
Jhansi
Jhansi
UTTAR PRADESH
284001
India
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9415073541 |
| Fax |
|
| Email |
drsudhirkumarmlb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
VP and R and D Head |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
Department of R&D
DATT MEDIPRODUCTS PVT LTD
52 to 54 63 and 64 Roz ka Meo industrial area Nuh Distt Mewat Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
9315829298 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
G M Clinical Research |
| Affiliation |
Datt Mediproducts Pvt Ltd. |
| Address |
Clinical Department
Datt Mediproducts Pvt Ltd 56 Community Center East of Kailash New Delhi
South
DELHI
110065
India
South
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt Mediproducts Pvt Ltd, 56, Community Center, East of Kailash, New Delhi, Delhi 110065 |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Pvt Ltd, |
| Address |
56, Community Center, East of Kailash, New Delhi, Delhi 110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Kumar |
Maharani Laxmi Bai Medical college & Associated Hospital |
Department of Plastic surgery, MLB Medical college & Associated Hospital
Kanpur road, Jhansi, Uttar Pradesh 284128
Jhansi
UTTAR PRADESH |
9415073541
drsudhirkumarmlb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharani Laxmi Bai Medical College & Associated Hospital, Jhansi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VELVERT Antimicrobial dressing indicated in the wounds caused due to Necrotising Soft tissue infection. (NSTI) |
Dressing to be changed every four day or earlier, for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female subjects within the age group of 18 to 70 years (both inclusive).
2. Subject with HbA1c level below 6.5 % (Well-controlled diabetes mellitus)
3. Subject with soft tissue infection caused by trauma, injury, burn, surgery.
4. Subjects with damaged deep layers of your skin that led to necrosis.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Subject unwilling or unable to comply with the follow up visits necessary for data collection.
2. Subject found positive for HIV, HBsAg and HCV.
3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
4. Pregnant females.
5. Subject with Immunosuppression, corticosteroids or chemotherapy.
6. Subject with decision making impairment.
7. Allergies to any material contained investigational devices. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A study outcome will be considered if below end points meet.
• Lesion/wound healed by 60 days (2 months) or prior
• Reduction of wound surface area within a time frame of 60 days (2 months). (Change in wound size) |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Number of patients achieve a complete wound closure or reduction in wound area by ≥ 50% by 60 days or earlier. (Change in wound area).
• Subject self-assessment of intensity of pain. (Pain scale from 0 to 10)
• Number of adverse events and wound complications either due to dressing material or other causes. (AE reported)
• Number of dressings required to achieve the change in wound size/ wound healing.
• Presence of micro-organism load on the last day of visit (Day 60 or earlier) (SWAB test) |
60 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
26/02/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
The study enrolled 20 patients with, "Necrotising soft-tissue infections fasciitis" and were treated with an anti-microbial dressing (VELVERT) for a duration of 60 days. Subjects were evaluated at the scheduled visits. First subject was enrolled on 16-Apr-2024. |