Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Study Overview
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Brief Summary
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Assess the effect of extracorporeal shock waves on hypertrophy scar

Detailed Description
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Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars. Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.

Official Title
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Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Conditions
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Hypertrophy; Scar

Intervention / Treatment
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* Device: extracorporeal shock-wave
* Other: massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18   65 years old; at least 4 weeks since onset of onset of wound; healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks the most important of all, read and signed the inform concern of this study. Exclusion Criteria: patients with open wound; oxygen dependent having evidence of cognitive deficit; having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT; patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extracorporeal shock-wave<br> | Device: extracorporeal shock-wave<br>* to treat painful and retracting scars<br>|
| Sham Comparator: massage<br> | Other: massage<br>* to treat painful and retracting scars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline thick of scar | sonography for thick of scar | immediately post intervention, 1 month after, and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Modified Vancouver Scar Scale | questionnaires of Modified Vancouver Scar Scale for scar measure | immediately post intervention, 1 month after, and 3 months | 
| change from baseline Visual analogue scores (VAS) | Visual analogue scores (VAS) for pain | immediately post intervention, 1 month after, and 3 months | 
| change from baseline skin color | DermaLab Combo series for skin color | immediately post intervention, 1 month after, and 3 months | 
| change from baseline Patient Scar Assessment Scale (POSAS) | questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure | immediately post intervention, 1 month after, and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn, hypertrophy scar