| CTRI Number |
CTRI/2026/02/104410 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to assess efficacy of platelet rich plasma with silver sulphadiazine versus silver sulphadiazine dressing in partial thickness burns |
|
Scientific Title of Study
|
A Randomised comparative study to assess efficacy of platelet rich plasma with silver sulphadiazine versus silver sulphadiazine dressing in partial thickness burns |
| 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 Anoosha Tresa Pius |
| Designation |
plastic Surgery Resident |
| Affiliation |
bangalore medical college |
| Address |
Fort, K.R. Road, Kalasipalyam, Bengaluru, Karnataka - 560002.
Bangalore
KARNATAKA
560002
India |
| Phone |
9645630588 |
| Fax |
|
| Email |
anushatresa43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesha K T |
| Designation |
Head of the Unit |
| Affiliation |
bangalore medical college |
| Address |
Plastic surgery department , 2 nd floor , PMSSY BUILDING , VICTORIA HOSPITAL , K R FORT, NEAR CITY MARKET , kalasipalyam
Bangalore
KARNATAKA
560002
India |
| Phone |
9645630588 |
| Fax |
|
| Email |
rameshktr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoosha Tresa Pius |
| Designation |
plastic Surgery Resident |
| Affiliation |
bangalore medical college |
| Address |
Plastic surgery department , 2 nd floor , PMSSY BUILDING , VICTORIA Hospital , K. R . FORT , near city market , KALASIPALAYAM,
Bangalore
KARNATAKA
560002
India |
| Phone |
9645630588 |
| Fax |
|
| Email |
anushatresa43@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bangalore medical college |
| Address |
Plastic surgery department , 2nd floor, PMSSY , VICTORIA HOSPITAL, Bangalore medical college,K.R. Road, Fort, Bengaluru - 560002.
Landmark: Near City Market. |
| Type of Sponsor |
Government 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 Anoosha Tresa Pius |
Bangalore Medical College |
plastic surgery department , 2 nd floor PMSSY BUILDING ,Victoria Hospital, K.R. Fort, near city market , Kalasipalyam Bengaluru - 560002, Karnataka, India
Bangalore
KARNATAKA |
9645630588
anushatresa43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of BMCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T311||Burns involving 10-19% of body surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUTOLOGOUS Platelet rich plasma with silver sulphadiazine |
Drop by drop, 7-8 CC of autologous PRP is gently poured onto the target area once in two days and allowed to dry for 15 minutes. PRP was used for 5 dressings ,every 2 days. After 15 minutes silver sulphadiazine is applied over wound in test group . |
| Comparator Agent |
Silver sulphadiazine |
Only Silver sulphadiazine is applied on. the wound (Standard treatment for burns ). Regular dressing with it are done . |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with a deep partial-thickness burn injury covering 1- 20 % TBSA
2) Patient willing to give informed consent
3) Both sexes with an age of 2-60 years.
4)Subjects who were younger than the legal consenting age must have a legally authorized representative.
5) isolated burn area (not involving head and/or face) |
|
| ExclusionCriteria |
| Details |
1)Subjects with inhalational injury or subjects being on a ventilator.
2)Treatment of the burn with an active agent before study entry.
3)Clinically infected burn
4)Diagnosed underlying disease(s) (e.g., HIV/AIDS, cancer, and severe anemia)
Judged by the investigator to be a potential interference in the treatment.
5) Use of immunosuppressive agents, radiation, or chemotherapy within the past 30d.
6) Subjects with physical and/or mental conditions who are not expected to comply with the investigation.
7) Pregnancy
8)Patient with haematological or coagulation disorders
9)Patients with any chronic skin disease
10) Electric or chemical burns
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing rate
(epithelisation rate)
Scar Score(Vancouver Scar Score)
Pain Score
Time until skin graft
Ease of removal of the dressing
|
dressing is done for 5 days , every alternate day , patients are studied and followed for 21 days - day 0, day 2, day 4, day 6, day 8, day 14 and day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/03/2026 |
| 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 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 - NO
|
|
Brief Summary
|
This study is a randomised comparative trial evaluating the efficacy of platelet rich plasma combined along with with silver sulphadiazine versus silver sulphadiazine alone in partial thickness burns. Silver sulphadiazine is the standard treatment but is associated with delayed healing pain and frequent dressing changes. Platelet rich plasma is an autologous blood product rich in growth factors that enhances angiogenesis epithelialization and tissue regeneration. Forty patients will be randomly assigned to two groups receiving either silver sulphadiazine alone or silver sulphadiazine with platelet rich plasma. Outcomes assessed include time to healing pain score scar score and need for skin grafting, easy pf change of dressing |