| CTRI Number |
CTRI/2024/12/078280 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Producing a new scar cream for burns patients which helps in scar lessening and wound healing |
|
Scientific Title of Study
|
Inventing a novel topical application called-DVolve SilverSoothe ScarCream- A Revolutionary Formulation for Scar Reduction and Wound Healing |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Vasireddy Divya |
| Designation |
Resident |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no 1, Department of general surgery, Saveetha Medical college and hospital,
Saveetha nagar, Thandalam,
Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
8886247666 |
| Fax |
|
| Email |
vasireddydivya86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no 5, Department of community medicine, Saveetha Medical college and hospital,
Saveetha nagar, Thandalam,
Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
8886247666 |
| Fax |
|
| Email |
vinaykumar.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasireddy Divya |
| Designation |
Resident |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no 1, Department of general surgery, Saveetha Medical college and hospital,
Saveetha nagar, Thandalam,
Chennai 602105
TAMIL NADU
602105
India |
| Phone |
8886247666 |
| Fax |
|
| Email |
vasireddydivya86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical
College and
Hospital,
Saveetha nagar, Thandalam,
Chennai 602105, Tamil Nadu,
India
|
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Medical college and hospital,
Saveetha nagar, Thandalam,
Chennai 602105, Tamil Nadu, India |
| Type of Sponsor |
Private medical college |
|
|
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 Vasireddy Divya |
Saveetha Medical College Hospital |
Room no 1, Department of general surgery, OP block, Saveetha Medical college and hospital,
Saveetha nagar, Thandalam,
Chennai 602105, Tamil Nadu, India
Chennai
TAMIL NADU |
8886247666
vasireddydivya86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DVolve SilverSoothe ScarCream for burns |
a topical cream for burn patients, incorporating a unique combination of colloidal silver, hydrogel, normal saline, and fibrin to minimize scar formation and enhance wound healing. It is given for 2 weeks. |
| Comparator Agent |
Silver nitrate cream |
Standard treatment followed in our hospital given for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with first-degree burns confirmed by medical assessment. Willing to participate in the study and provide informed consent. Available for follow-up assessments as required and able to understand and comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
Patients with burns other than first-degree e.g., second-degree, third-degree burns. Age below 18 years. Inability to provide informed consent e.g., cognitive impairment, Presence of pre-existing conditions that may affect burn healing e.g., diabetes, immunocompromised status, Pregnancy, as hormonal changes may impact burn healing. Unwillingness or inability to comply with study procedures or follow-up assessments.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the effectiveness of a novel cream in promoting wound healing and reducing scar formation in patients with first-degree burns |
0, 3, 6, 9, 12, 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A. Evaluate the efficacy of the novel cream in relieving pain associated with first-degree burns |
0, 3, 6, 9, 12, 15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vasireddydivya86@gmail.com].
- For how long will this data be available start date provided 12-06-2025 and end date provided 20-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective study done to evaluate the efficacy and safety of
the cream in 30 first degree burn patients in Saveetha Medcial college and hospital. Patients with first-degree burns confirmed by medical
assessment. Age 18 years and above. Willing to participate in the study and provide
informed consent. Available for
follow-up assessments as required. Able to
understand and comply with study procedures are included in the study. Patients with
burns other than first-degree (e.g., second-degree, third-degree burns).Age below 18
years. Inability to
provide informed consent (e.g., cognitive impairment), Presence of
pre-existing conditions that may affect burn healing (e.g., diabetes,
immunocompromised status), Pregnancy, as
hormonal changes may impact burn healing, Unwillingness or
inability to comply with study procedures or follow-up assessments are excluded from the study. Patient surveys
or questionnaires administered to gather subjective feedback on pain levels,
scar appearance, and overall satisfaction with the cream’s effectiveness. Objective
measurements such as scar dimensions, tissue elasticity, and wound healing
rates obtained through clinical assessments conducted by trained healthcare
professionals Laboratory
analyses of biological samples (e.g., skin biopsies) to evaluate histological
changes, cytokine levels, and other biomarkers associated with wound healing
and scar formation. Documentation of
adverse events, medication adherence, and other relevant clinical data obtained
from patient medical records and follow-up appointments. |