| CTRI Number |
CTRI/2025/02/081177 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study of scar outcomes in patients undergoing Dermaroller treatment with or without Platelet rich plasma (PRP) |
|
Scientific Title of Study
|
Observational study of scar outcomes in patients undergoing
microneedling with or without Platelet rich plasma (PRP)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanvi Rao |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Department of Plastic Surgery
Kasturba Medical college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483928989 |
| Fax |
|
| Email |
tanvi.rao@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanvi Rao |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Department of Plastic Surgery
Kasturba Medical college, Manipal
KARNATAKA
576104
India |
| Phone |
9483928989 |
| Fax |
|
| Email |
tanvi.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Tanvi Rao |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Department of Plastic Surgery
Kasturba Medical college, Manipal
KARNATAKA
576104
India |
| Phone |
9483928989 |
| Fax |
|
| Email |
tanvi.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tanvi Rao |
| Address |
Department of Plastic Surgery
Kasturba Medical college, Manipal
India
576104 |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Tanvi Rao |
Kasturba Medical college |
Department of Plastic Surgery
Kasturba Medical college, Manipal
Udupi
KARNATAKA |
9483928989
tanvi.rao@manipal.edu |
| Tanvi Rao |
Kasturba Medical college, Manipal |
Kasturba Medical college, Manipal
Karnataka
Udupi
Udupi
KARNATAKA |
9483928989
tanvi.rao@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L919||Hypertrophic disorder of the skin,unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Scars secondary to trauma, burns or surgery
Patient of any age if informed consent is obtained for the study by the patient or the guardian
Patients who are not using other therapies for scar management |
|
| ExclusionCriteria |
| Details |
Patients who do not provide informed consent for the procedure
Patients using other modalities of treatment for scar management
Patients who have had permanent filler injections to scars
Patients who are lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate outcomes of
scars in patients undergoing microneedling and/or Platelet Rich Plasma (PRP) |
every 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate POSAS score
scars in patients undergoing microneedling and/or Platelet Rich Plasma (PRP) |
every 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 - NO
|
|
Brief Summary
|
Aims & objectives (hypotheses if applicable): Our aim in this study is to evaluate outcomes of
scars in patients undergoing microneedling and/or Platelet Rich Plasma (PRP). Justification for study (whether of national significance with rationale): Scars are the most
common problems associated with burns, trauma or surgery. There are various modalities available to
manage and improve scar outcomes which are used regularly as standard of care practices in our
department. Of these, Microneedling (dermarolling) and platelet rich plasma (PRP) are cost-effective
outpatient procedures that can help improve scar quality and patient satisfaction. It can thus be a very
useful modality in the management of scars. |