| CTRI Number |
CTRI/2024/09/073934 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Treatment for Scar |
|
Scientific Title of Study
|
Comparison Of Nano Fat Grafting With Pressure Therapy vs Pressure Therapy Alone in Hypertrophic Scar and Keloid |
| 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 Prajwal P Rajolli |
| Designation |
First Year Post Graduate |
| Affiliation |
Shyam Shah Medical College, Rewa |
| Address |
Department of General Surgery, Shyam Shah Medical College, Hari Bhushan Nagar, near Dhobiya Tank, Rewa 486001
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7259411829 |
| Fax |
|
| Email |
rajolliprajwal.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Saxena |
| Designation |
Associate Professor |
| Affiliation |
Shyam Shah Medical College, Rewa |
| Address |
Block no 1, Flat no 3, New Doctors Colony, Arjun Nagar Rewa 486001
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9825935433 |
| Fax |
|
| Email |
saurabhsaxenarewa1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Saxena |
| Designation |
Associate Professor |
| Affiliation |
Shyam Shah Medical College, Rewa |
| Address |
Block no 1, Flat no 3, New Doctors Colony, Arjun Nagar Rewa 486001
MADHYA PRADESH
486001
India |
| Phone |
9825935433 |
| Fax |
|
| Email |
saurabhsaxenarewa1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Shyam Shah Medical College, Hari Bhushan Nagar, Near Dhobiya Tank, Rewa 486001, Madhya Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Prajwal P Rajolli |
| Address |
Department of General Surgery, Shyam Shah Medical College, Hari Bhushan Nagar, Near Dhobiya Tank, Rewa 486001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prajwal P Rajolli |
Sanjay Gandhi Memorial Hospital |
Burn unit, Department of General Surgery, Shyam Shah Medical College, Hari Bhushan Nagar, Rewa 486001
Rewa
MADHYA PRADESH |
7259411829
rajolliprajwal.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shyam Shah Medical College, Rewa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nano Fat Grafting With Pressure Therapy in Hypertrophic Scar and Keloid |
Nano Fat Grafting followed by Pressure Therapy for 6 months done in patients of Hypertrophic Scar and Keloid and assessed at 1 month and 6 months for scar regression. |
| Comparator Agent |
Pressure Therapy in Hypertrophic Scar and Keloid |
Pressure Therapy for 6 months done in same patients at other site of Hypertrophic Scar and Keloid and assessed at 1 month and 6 months for scar regression. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Hypertrophic Scar and Keloids |
|
| ExclusionCriteria |
| Details |
Patients with bleeding disorders, Pregnancy, under Steroid Therapy, Associated Infection, anti neoplastic, immunosuppressants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Regression of the Scar
2. Normalisation of Scar Pigmentation and Texture |
1 to 6 months from day of treatment / intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Partial regression of the scar |
1 to 6 months from day of treatment / intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients with Hypertrophic Scars and Keloids are treated by two modalities. Every patient with multiple scars are treated with Nano Fat grafting followed by Pressure Therapy at one site of scar and at other site treated by only Pressure Therapy with coconut oil massage and compression crepe bandage. Both the sites are assessed for scar regression at a month and 6 months of interval from the day of start of intervention. Also both the sites of scar are assessed by Vancouver Scar Scale and POSAS before intervention, after 1 month and 6 months of intervention to find out which modality has better outcome. |