| CTRI Number |
CTRI/2025/11/098213 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To look for improvement in scar quality of unsighty scars over exposed body parts following excision with injection of SVF (substance derived from patients own fat) versus excision of scar alone in a study where the patients also know to which of the above group they belong. |
|
Scientific Title of Study
|
Comparison of outcomes in patients undergoing scar revision with infiltration of adipose derived stromal vascular fraction versus scar revision alone: An Open Label Randomised Control Trial |
| Trial Acronym |
SVF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mary Treasa Pouline |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Burns and Plastic Surgery, All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9400542626 |
| Fax |
|
| Email |
riniraymondmorris@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarsij Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Burns and Plastic Surgery, All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7042156227 |
| Fax |
|
| Email |
drsarsijsharma@aiimspatna. org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarsij Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Burns and Plastic Surgery, All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7042156227 |
| Fax |
|
| Email |
drsarsijsharma@aiimspatna. org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
Department of Burns and Plastic Surgery |
| Address |
5th floor, Department of Burns and Plastic Surgery, All India Institute of Medical Sciences, Patna |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mary Treasa Pouline |
All India Institute of Medical Sciences, Patna |
Room 543, 5th floor, OPD building, Department of Burns and Plastic surgery, All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar, India 801507
Patna
BIHAR |
9400542626
riniraymondmorris@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scar revision |
Scar excised and resultant wound sutured with finer sutures |
| Intervention |
Scar revision with infiltration of adipose derived stromal vascular fraction |
Scar excised and resultant wound sutured with finer sutures. 20ml liposuction done under Local anaesthesia. Centrifuged and emulsified manually by passing between syringes and again centrifuged to extract stromal vascular fraction which is injected into the suture line |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Excessive scars (wide, atrophic and hypertrophic scars) following surgery, trauma or burn on the face, neck, forearm and hand for more than 1 year
2. Scar length less than 10cm and width less than 5cm
3. Not a part of any other trial or research project
4. BMI more than 20 |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation
2. Previous scar treatments for the same scar
3.Skin malignancies
4.Connective tissue disorders
5.Keloids
6.Not willing for consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scar measurements based on clinical and ultrasound measurements and Quality by POSAS score |
scar measurements based on clinical and ultrasound measurements and Quality by POSAS score at baseline and 6 months post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/12/2025 |
| 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="0"
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
|
Study investigates whether intraoperative infiltration of adipose-derived stromal vascular fraction (SVF) during scar revision improves scar quality and reduces scar width compared to scar revision surgery alone in patients with scars over exposed areas such as the face, neck, forearm, and hand. The study recruits subjects aged 15–45 with scars longer than one year and measures outcomes using both clinical and ultrasound scar width evaluations, as well as the Patient and Observer Scar Assessment Scale (POSAS). There are two arms: one group receives SVF infiltration in addition to scar revision, while the other receives only conventional scar revision. Methodology includes the extraction and mechanical processing of adipose tissue for SVF preparation and standardized intraoperative administration. A minimum sample size of 52 (26 per group) is calculated and block randomization ensures balanced allocation. The primary outcomes are assessed six months post-procedure. The study intends to generate evidence for the effectiveness of SVF in improving surgical scar outcomes, potentially influencing clinical practice in scar management |