An interventional study of pulsed high intensity laser therapy and Extracorporeal shockwave therapy in Hypertrophic Scar, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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 :
Subjects :
Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years.
In this study, the patients will be randomly divided into two equal groups in number (30 patients each).
Group A (pulsed high intensity laser group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week.
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive Extracorporeal shockwave therapy in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be two times per week.
Equipments :
.Measurement equipments :
Modified Vancouver burn Scar assessment scale :
Modified Vancouver scar scale (VSS), an observer-dependent scale of the macroscopic appearance of scarring, was 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.To assess 3 variables of scar characteristics: Vascularity, pliability and height.
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)
This scale 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.
To assess scar pliability and elasticity improvement by an objective manner 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 pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg .
Treatment procedure :
Pulsed High Intensity Laser application procedure:
Extracorporeal shockwave application procedure:
conservative treatment for both groups: (Stretching exercises and Deep friction massage ) 2 sessions per week for 6 weeks
129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.
Browse Cicatrix, Hypertrophic studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: pulsed high intensity laser therapy
Device: Extracorporeal shockwave therapy
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 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 .
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)
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)
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2025; primary completion for Feb 2025, 0 months later.
Of 33 interventional studies with no phase under Cicatrix, Hypertrophic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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