| CTRI Number |
CTRI/2020/12/029698 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized, open label, single centre, post market clinical study to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to Silver Sulfadiazine in the treatment of second degree burn wounds. |
|
Scientific Title of Study
|
A randomized, open label, single centre, post market clinical study (PMS) to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to Silver Sulfadiazine in the treatment of second degree burn wounds. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/P20-2019/CT/VV; Version 1.0; Dated 10-OCT-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Goutam Guha |
| Designation |
Professor and HOD Dept of Plastic Surgery |
| Affiliation |
IPGME and R Kolkata |
| Address |
IPGME and R
Ronald Ross Building 2nd Floor
244 AJC BOSE ROAD KOLKATA 20 INDIA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830050145 |
| Fax |
|
| Email |
drgguha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Goutam Guha |
| Designation |
Professor and HOD Dept of Plastic Surgery |
| Affiliation |
IPGME and R Kolkata |
| Address |
IPGME and R
Ronald Ross Building 2nd Floor
244 AJC BOSE ROAD KOLKATA 20 INDIA
WEST BENGAL
700020
India |
| Phone |
9830050145 |
| Fax |
|
| Email |
drgguha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Head Research and Development |
| Affiliation |
Datt mediproducts Pvt. Ltd. |
| Address |
56 Community Centre East of Kailash New Delhi 110065 India
South
DELHI
110065
India |
| Phone |
01147191777 |
| Fax |
|
| Email |
lifescience@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| The Clinical trial is insured and the monetary support will be given by the sponsor. |
| The trial will be conducted at SSKM hospital, in the department of Plastic surgery, IPGMER, Kolkata, West Bengal |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Private Limited |
| Address |
56 Community Centre East Of Kailash New Delhi – 110065 India |
| 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 |
| Prof Dr Goutam Guha |
IPGME and R |
IPGME and R,
Ronald Ross Building, 2nd. Floor;
244 AJC BOSE ROAD, KOLKATA- 700020, INDIA
Kolkata
WEST BENGAL |
9830050145
drgguha@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IPGME and R oversight committee (Institutional Ethics committee) |
Approved |
| IPGME and R research oversight committee (Institutional Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Silver Sulfadiazine |
Silver Sulfadiazine Cream IP 1% w/w |
| Intervention |
VELVERT (new antimicrobial wound dressing) |
VELVERT is a non-adherent topical wound dressing which is loaded with antimicrobial formulation of F-10 (Curcuma longa Extract, Phyllanthus emblica Extract and Camellia sinensis Extract) on polymeric sponge which is made up of biopolymers (Gelatin and Chitosan). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult non-diabetic male and female subjects of the age group between 18 to 70 years.
2. Subjects with second-degree burn wounds
3. Total Body Surface Area of burns 5% to 20%
4. Subjects/ LAR must be able to read and understand informed consent, and sign the informed consent to provide data for the study
5. Subjects who allow their data to be collected for the study at predefined follow-up periods
6. All sexually active female subjects of childbearing potential without any clinical evidence of pregnancy |
|
| ExclusionCriteria |
| Details |
1. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
2. Subjects found positive for HIV 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. Comorbidities which could interfere with clinical evaluations or interpretation of results
6. Subjects with known allergy to the constituents of investigational products/ device.
7. Subjects with immunosuppression, corticosteroids or chemotherapy
8. Subjects with a severe comorbid disorder, not expected to survive more than 12 months.
9. Subjects requiring concomitant use of negative pressure wound therapy (NPWT) on the reference wound
10. Poor adaptivity or seriously ill subjects who cannot finish the observation period
11. Any other condition which, according to the judgment of the investigator, could interfere in the study
12. Subjects with Diabetic foot ulcer and Infected wound. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i) Evaluation of total wound area (sum of areas of all present wounds on both limbs) has completely closed, compared to baseline (inclusion), on or before the scheduled last visit (Day 24)
(ii) Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visit |
24 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparative evaluation of the number of complete wound closures by day 24
2.Number of subjects reporting relief from pain
Comparative evaluation of subjects will record their subjective pain level
3.Number of adverse events either due to dressing material or other causes
4. Assessment of TLC and DLC values.
|
24 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the efficacy of a new antimicrobial wound dressing (VELVERT) to treat second degree burn wounds compared to Silver Sulfadiazine in terms of healing rates based on clinical evaluation and wound photographs analysis. |