| CTRI Number |
CTRI/2024/05/068198 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between The Effectiveness Of Two Types Of Blood Concentrates In Facial Scars. |
|
Scientific Title of Study
|
A Comparative Study On Efficacy Of Injectable Platelet Rich Fibrin (i-PRF) And Platelet Rich Plasma (PRP) In Facial Scars - A Triple Blinded Randomized Clinical Trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narasimhadevara Santha Lakshmi Pratyusha |
| Designation |
post graduate |
| Affiliation |
Anil Neerukonda Institute Of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
8187820402 |
| Fax |
|
| Email |
pratyusha2820046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Phani Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute Of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
8096339404 |
| Fax |
|
| Email |
raghu8099@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Nagamalleswara Rao |
| Designation |
Professor |
| Affiliation |
Anil Neerukonda Institute Of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9618170810 |
| Fax |
|
| Email |
malli.maxface@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam, Andhra Pradesh,India 531162 |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam, Andhra Pradesh, India 531162 |
| 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 Narasimhadevara Santha Lakshmi Pratyusha |
Anil Neerukonda Institute of Dental Sciences |
Room no 3, Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
8187820402
pratyusha2820046@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- Anil Neerukonda Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S019||Open wound of unspecified part ofhead, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable - Platelet Rich Fibrin (i-PRF) |
blood will be collected into a plain vacutainer from the participant and will be centrifuged at 700rpm from 3min and i-PRF is extracted and will be injected into the facial scar |
| Comparator Agent |
Platelet Rich Plasma (PRP) |
blood will be collected into a EDTA vacutainer from the participant and will be centrifuged, 1st step at 900rpm for 5min and 2nd step at 2000rpm for 15min. PRP is taken and will be injected into the facial scar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Scars secondary to surgical incision and trauma.
2. Scars involving head and neck region.
3. Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Scars secondary to burns, acne.
2. Scars that received any previous revision/treatment.
3. Patients with history keloid tendency, any active skin/systemic conditions, immunosuppression, bleeding and clotting disorders, pregnancy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| surface area of the scar |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pigmentation and texture |
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - Study Protocol
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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pratyusha2820046@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
1. Aim of this study is to compare the efficacy between Injectable Platelet-Rich Fibrin (i-PRF) and Platelet-Rich Plasma (PRP) in the treatment of Facial Scars. Patients
who report with chief complaint of facial scar to the Department of
Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental
Sciences, Visakhapatnam. Careful evaluation & selection of participants. Written Informed Consent will be taken from selected participants & Preoperative Patient and Observer Scar Assessment Scale (POSAS) will be taken respectively. The co- investigator will be helping in blinding and allocation concealment. The participants will be randomly assigned to Group A & Group B. Both the Principal Investigator and Participant will be blinded. The Co-investigator will be helping with randomization, blinding and Allocation concealment. The Evaluator, who is blinded,
will assess Postoperative outcomes one month after the last session in
all the participants from both the groups by Patient and Observer Scar
Assessment Scale (POSAS). The collected data will be consolidated and statistically analyzed.
3.
|