| CTRI Number |
CTRI/2024/08/072654 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of artificial skin in management of post burn contractures |
|
Scientific Title of Study
|
Role of dermal matrix and skin grafting in resurfacing of defects following release of burn contractures |
| 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. Nemi Amit Patel |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of burns and plastic surgery,
Vardhman Mahavir medical college and Safdarjung Hospital,
New Delhi 110029
South West
DELHI
110029
India |
| Phone |
8460636627 |
| Fax |
|
| Email |
imnemipatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sujata Sarabahi |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
First floor HOD Office ,
Department of burns and plastic surgery,
Vardhman Mahavir medical college and Safdarjung Hospital,
New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9810054396 |
| Fax |
|
| Email |
drssarabahi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nemi Amit Patel |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of burns and plastic surgery,
Vardhman Mahavir medical college and Safdarjung Hospital,
New Delhi 110029
South West
DELHI
110029
India |
| Phone |
8460636627 |
| Fax |
|
| Email |
imnemipatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College And Safdarjung Hospital,
Ansari nagar west,
New Delhi
Delhi
110029
India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,
ansari nagar west,
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 Nemi Amit Patel |
Vardhman Mahavir medical college and Safdarjung Hospital |
Department Of Burns and Plastic Surgery,
Vardhman Mahavir Medical College and Safdarjung Hospital,
ansari nagar west,
New Delhi
110029
South West
DELHI |
08460636627
imnemipatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Limb contractures following thermal burn and requiring release. |
|
| ExclusionCriteria |
| Details |
Allergic history
Pregnant or Breast feeding patients
Autoimmune disorders or immunosuppressive disorders
uncontrolled Diabetes mellitus type 2 or hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aesthetic outcome |
1,3, and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Graft loss
2) Histological finding
3) functional outcome |
1) 7 and 14 days
2) 3 months
3) 3 and 6 month |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
26/08/2024 |
| 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 - NO
|
|
Brief Summary
|
To study the role of dermal matrix and skin grafting in resurfacing of defects following release of burn contractures and to assess the aesthetic outcomes in the areas resurfaced using dermal matrix and skin grafting following release of burn contracture . |