| CTRI Number |
CTRI/2019/04/018804 [Registered on: 26/04/2019] Trial Registered Prospectively |
| Last Modified On: |
13/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to Compare the use of pigment producing[Melanin] Cell Suspension[taken from the skin] With Skin Grafting On Adequate Re-pigmentation Of white patches seen post burns |
|
Scientific Title of Study
|
Comparison Of The Efficacy Of Autologous Non- Cultured Melanocyte – Keratinocyte Cell Suspension With Split Skin Grafting On Adequate Re-pigmentation Of Post Burn Leukoderma: A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2018/0251 (Date of IEC clearance : 28/08/2018) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chirra Likhitha Reddy |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research [JIPMER] |
| Address |
Dept of Plastic Surgery
4th floor,
Superspeciality block
JIPMER
Pondicherry
Dhanvanthri Nagar,
Gorimedu
Pondicherry- 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9581241574 |
| Fax |
04132272066 |
| Email |
drlikhithareddy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devi Prasad Mohapatra |
| Designation |
Additional Proffessor |
| Affiliation |
JIPMER |
| Address |
Department of plastic surgery,
4th floor, SSB,
JIPMER,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7418282494 |
| Fax |
04132272066 |
| Email |
devimohapatra1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devi Prasad Mohapatra |
| Designation |
Additional Proffessor |
| Affiliation |
JIPMER |
| Address |
Department of plastic surgery,
4th floor, SSB,
JIPMER,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7418282494 |
| Fax |
04132272066 |
| Email |
devimohapatra1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Dhanvatri Nagar,
Gorimedu
Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education & Research
JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry-605 006 |
| 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 Likhitha Reddy |
Department of Plastic Surgery, Superspeciality Block, JIPMER |
Jawahar Lal Institute of Post Graduate Medical Education & Research
Dhanvantri Nagar, Gorimedu, Pondicherry - 605 006, India
Pondicherry
PONDICHERRY |
09581241574
drlikhithareddy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human studies) JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Non Cultured Melanocyte Keratinocyte cell suspension |
Dermabrasion of the leucoderma patch and application of Autologous Non Cultured Melanocyte Keratinocyte cell suspension over the dermabraded area |
| Comparator Agent |
Split skin grafting |
Dermabrasion of the leucoderma patch and fixation of the split skin graft over the dermabraded area |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patient with post burn leukoderma who attend the JIPMER plastic surgery outpatient department
Age more than 12 years |
|
| ExclusionCriteria |
| Details |
i.Any previous surgical treatments for post burn leukoderma in the past 1 year
ii.Patients with ulcers over the hypopigmented patches
iii.Patients with keloid tendency
iv.Patients with autoimmune diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Repigmentation
Graded based on the percentage of repigmentation of the treated areas as follow
Excellent - 90-100% pigmentation,
Good - 50-89%,
Fair - 20-49%
Poor - 0-20% |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
3months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2019 |
| Date of Study Completion (India) |
25/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to identify the efficacy of autologous non cultured melanocyte keratinocyte cell suspension in relation to the standard care of split skin grafting in patients with post burn leucoderma patches
Research Hypothesis: Autologous non-cultured melanocyte keratinocyte cell suspension is more effective in producing adequate re-pigmentation than split skin grafting in post burn leukoderma at 3 months |