| CTRI Number |
CTRI/2018/08/015147 [Registered on: 01/08/2018] Trial Registered Prospectively |
| Last Modified On: |
01/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Low Level Laser Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effect of Low Level Laser Therapy (LLLT) on post burn scars |
|
Scientific Title of Study
|
Effect of Low Level Laser Therapy (LLLT) on severity of post burn immature scars: A randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2017/0393 (date of IEC clearance: 02/05/2018) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Gupta |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry |
| Address |
Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9981856366 |
| Fax |
|
| Email |
drsaurabh2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar Chittoria |
| Designation |
Professor and Registrar (Academic) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry |
| Address |
Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442285670 |
| Fax |
|
| Email |
drchittoria@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Kumar Chittoria |
| Designation |
Professor and Registrar (Academic) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry |
| Address |
Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442285670 |
| Fax |
|
| Email |
drchittoria@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Puducherry |
| Address |
Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry |
| 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 Saurabh Gupta |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry |
Department of Plastic Surgery,
4th floor, Superspeciality Block,
Jawaharlal Institute of Postgraduate Medical Education and
Research (JIPMER)
Puducherry
Pondicherry
PONDICHERRY |
9981856366
drsaurabh2007@gmail.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: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Therapy
(Low Level Laser Therapy, Conventional therapy: scar massage and compression garments) |
Low Level Laser Therapy:
Gallium Arsenide (GaAs) Diode Red Laser Wavelength 650 nm Energy density 4 J/cm² Output power 100 mW Frequency 10 kHz Duration 125 sec Continuous beam
Interval: twice a week (not less than 3 days interval between two therapies) Non contact delivery (60cm distance between laser source and scar) Scanning mode |
| Comparator Agent |
Conventional therapy alone |
Scar massage and compression garments |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with post burn immature scars (vascular, raised, non pliable or itchy) |
|
| ExclusionCriteria |
| Details |
Subjects with acute burn wounds (<1month old) Subjects with age <18 years and >60 years Subjects with diabetes/ radiation exposure Scars near eyes
Scars >4 square feet area
Subjects not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vancouver Scar Scale (VSS) score of the scar |
At the time of enrolment of the scar in the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vancouver Scar Scale (VSS) score of the scar |
After eight weeks of intervention over the scar |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/08/2018 |
| Date of Study Completion (India) |
07/10/2019 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title of the study: Effect
of Low Level Laser Therapy (LLLT) on severity of post burn immature scars: A randomized
control study. Research question: What is the effect of combined therapy (LLLT +
conventional therapy) on severity of scars compared to conventional therapy
alone among the patients with post burn immature scars? Research hypothesis: Combined therapy is more effective than
conventional therapy in reducing the severity of scars among the patients with
post burn immature scar. Introduction: A. Problem statement: A mature scar is flat, soft and supple with
color matching with that of the surrounding skin. An immature scar is a red, sometimes
itchy or painful and slightly elevated scar in the process of remodeling.
Immature scars undergo repeated scar breakdown. This is a major problem in the
post burn patients during rehabilitation phase. Various measures
exist including Low level Laser Therapy (LLLT) to make the immature scar
mature. No study has been reported from India on effect of LLLT on post burn
immature scar. B. Rationale: LLLT is claimed to increase collagen synthesis, decrease
inflammation and has positive impact on scar remodeling. LLLT is one of the
standard and safe treatments for immature scars. It can be utilized to promote
faster maturation of post burn scars. C. Novelty: Limited clinical studies are available on effect of LLLT
on severity of post burn scars. D. Expected outcome and application: Low Level Laser (LLL) has
positive effect on post burn immature scar is expected. Based on outcome of
this study role of Low Level Laser Therapy (LLLT) may be established as an
adjunct in the management of post burn immature scars. This will be useful in
rehabilitation of post burn patients. Aim and objectives: Aim: To assess
the effect of LLLT on severity of the scars among the patients with post burn
immature scars. Primary Objective: To assess
efficacy of combined therapy (LLLT + conventional treatment) on severity of
post burn immature scars in comparison with conventional treatment alone. Secondary
Objective: To identify the
clinical factors associated with the efficacy of LLLT on treatment of post burn
immature scars.
|