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Clinical Trials/CTRI/2018/08/015147
CTRI/2018/08/015147CompletedUnknown

Effect of Low Level Laser Therapy (LLLT) on severity of post burn immature scars: A randomized control study.

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Puducherry1 site in 1 country45 target enrollmentStarted: August 8, 2018Last updated:

Trial Snapshot

Phase
Unknown
Status
Completed
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
Vancouver Scar Scale (VSS) score of the scar

Study Overview

Brief Summary

Title of the study: Effectof Low Level Laser Therapy (LLLT) on severity of post burn immature scars: A randomizedcontrol study.

Research question: What is the effect of combined therapy (LLLT +conventional therapy) on severity of scars compared to conventional therapyalone among the patients with post burn immature scars?

Research hypothesis: Combined therapy is more effective thanconventional therapy in reducing the severity of scars among the patients withpost burn immature scar.

Introduction:

A.    Problem statement: A mature scar is flat, soft and supple withcolor matching with that of the surrounding skin. An immature scar is a red, sometimesitchy or painful and slightly elevated scar in the process of remodeling.Immature scars undergo repeated scar breakdown. This is a major problem in thepost burn patients during rehabilitation phase. Various measuresexist including Low level Laser Therapy (LLLT) to make the immature scarmature. No study has been reported from India on effect of LLLT on post burnimmature scar.

B.    Rationale: LLLT is claimed to increase collagen synthesis, decreaseinflammation and has positive impact on scar remodeling. LLLT is one of thestandard and safe treatments for immature scars. It can be utilized to promotefaster maturation of post burn scars.

C.   Novelty: Limited clinical studies are available on effect of LLLTon severity of post burn scars.

D.   Expected outcome and application: Low Level Laser (LLL) haspositive effect on post burn immature scar is expected. Based on outcome ofthis study role of Low Level Laser Therapy (LLLT) may be established as anadjunct in the management of post burn immature scars. This will be useful inrehabilitation of post burn patients.

Aim and objectives:

Aim: To assessthe effect of LLLT on severity of the scars among the patients with post burnimmature scars.

Primary Objective: To assessefficacy of combined therapy (LLLT + conventional treatment) on severity ofpost burn immature scars in comparison with conventional treatment alone.

SecondaryObjective: To identify theclinical factors associated with the efficacy of LLLT on treatment of post burnimmature scars.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects with post burn immature scars (vascular, raised, non pliable or itchy).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Vancouver Scar Scale (VSS) score of the scar

Time Frame: At the time of enrolment of the scar in the study

Secondary Outcomes

  • Vancouver Scar Scale (VSS) score of the scar(After eight weeks of intervention over the scar)

Investigators

Sponsor
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Puducherry
Sponsor Class
Government medical college

Study Sites (1)

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