| CTRI Number |
CTRI/2024/09/073439 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Platelet rich plasma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficiency of platelet rich plasma with antimicrobial dressing compared with antimicrobial dressing alone in healing of acute second degree burns |
|
Scientific Title of Study
|
Comparison of platelet rich plasma with antimicrobial dressing versus antimicrobial dressing alone in healing of acute second degree 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 |
Sugandh Gumber |
| Designation |
Senior resident |
| Affiliation |
Vmmc and safdarjung hospital |
| Address |
Department of burns and plastic surgery, Vmmc and safdarjung hospital, new delhi
New Delhi
DELHI
110029
India |
| Phone |
9023744126 |
| Fax |
|
| Email |
Gumbersugandh@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Harish kumar sharma |
| Designation |
Professor |
| Affiliation |
Vmmc and safdarjung hospital |
| Address |
Department of burns and plastic surgery, Vmmc and safdarjung hospital, new delhi
New Delhi
DELHI
110029
India |
| Phone |
9968094834 |
| Fax |
|
| Email |
drharishpls@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sugandh Gumber |
| Designation |
Senior resident |
| Affiliation |
Vmmc and safdarjung hospital |
| Address |
Department of burns and plastic surgery, Vmmc and safdarjung hospital, new delhi
New Delhi
DELHI
110029
India |
| Phone |
9023744126 |
| Fax |
|
| Email |
Gumbersugandh@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Safdarjung hospital new delhi India. 110029 |
|
|
Primary Sponsor
|
| Name |
Safdarjung hospital |
| Address |
VMMC and safdarjung hospital, new delhi 110029 |
| 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 Sugandh gumber |
Safdarjung hospital |
Departments of burns, plastic and maxillofacial surgery, Vmmc and Safdarjung hospital
New Delhi
DELHI |
9023744126
Gumbersugandh@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee vardhman mahavir medical college and Safdarjung hospital |
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 |
Antimicrobial dressing alone |
Dressing of burn wound with silver impregnated dressing 3 applications biweekly |
| Intervention |
Application of PRP along with antimicrobial dressing |
3 application of prp to burn wound along with antimicrodressing on biweekly basis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presentation within 24 hours of burn
Second degree burns
Upto 30% TBSA |
|
| ExclusionCriteria |
| Details |
Presence of comorbidities such as renal insufficiency, DM, immunosuppressive state
Burns due to electric contact or chemical agents
Patients with wound exclusively over face and genitalia
Malignancy
Pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of burn wound |
Post burn day 7, 14 21, 28. And 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of epithelialisation
Microbial culture from wound
Scar assessment |
Post burn day 7, 14, 21, 28 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
13/09/2024 |
| 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="8"
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
|
After written and informed consent, 34 patients with acute second degree burn wounds who meet the inclusion criteria will be selected. To minimize comparability related errors, intrapatient cases and control areas of size 10*10 cm size will be selected and treated with either topical prp with antimicrobial dressing or antimicrobial dressing alone. Wound healing will be assessed and compared at 7,14,21,28 days and 3 months post burn |