Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCairo University

About this trial

The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.

The main questions is it aims to answer is :

* Which is more effective on hypertrophic scar post burn Extracorporeal shockwave therapy or pulsed high intensity laser therapy? * Participants will receive the treatment for 6 weeks. * Assesment will be don before and after treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The patients age will range from 20 to 45 years.

All patients will be free from any other pathological conditions or histories except hypertrophic scar.

patients will be selected from both gender.

All patients will have hypertrophic scars post burn injuries.

Disqualifiers

The patients who have open wound at or near treatment site.

The patients who have cardiac pacemakers or other implanted electronic devices.

The patients who have any significant health problem such as diabetes, circulatory

disorders or history of skin malignancy in the treated area.

Trial design

Design model

Parallel

Treatments tested in this trial

  • pulsed high intensity laser therapy

    Device

    The high-intensity laser therapy (HILT), which involves laser radiation with high-intensity, is a kind of novel and powerful . The HILT possesses its own photomechanical, photothermal, and the photo-chemical properties.

  • Extracorporeal shockwave therapy

    Device

    Extracorporeal shockwave therapy is an acoustic wave that mechanically disrupts tissue by cavitation.Shock waves develop microscopic injuries in scar tissue and break down collagen fibers which lead to scar remodelin .The patient is positioned in a comfortable position. The scar site is prepared with contact gel to conduct the shock waves, 30-50 shocks/cm2 , with an energy flux density of 0.25mJ/mm2 and a frequency of 6Hz. Each treatment region is covered with 2500 to 3000 impulses with an average session time of 10-15min .

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: study group receives pulsed high intensity laser and coservative treatmentActive comparator 1 intervention
Group B: study group receives extracorporeal shockwave therapy and coservative treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Vancouver burn Scar assessment scale

Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score).

Time frame
change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)

Secondary outcomes

1

Aschiotz tonometer device

Aschiotz tonometer device, will be used as an objective scale to asses the hypertrophic scar pliability and elasticity. The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg.

Time frame
change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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