The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars

Study Overview
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Brief Summary
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A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks. The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.

Official Title
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Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars

Conditions
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Cicatrix, Hypertrophic

Intervention / Treatment
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* Device: Extracorporal Shock Wave Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypertrophic post burn scars of approximately 64 cm2 surface area. Exclusion Criteria: Patients younger than 18 year. Pregnant women. Having a known skin condition (e.g. psoriasis, skin cancer etc.). Immunosuppression. Hemophilia . Matured scars. Scars located above the lungs, the bowels, the gonads or electronic implants.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Two randomized groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group (ESWT) received the standard treatment and treatment of postburn scars with ESWT 512 impulses of o.15mJ/mm 2 in each session, twice per week for 4 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This group received pain and pruritus medication as needed, received the usual physical therapy as per the protocol of our burn unit, as well as compression garments, silicone sheets and gels and moisturizing cream twice a day. Additionally, the patients were advice on reducing sun exposure and applying +50SPF sunblock on a daily basis. | |
| Experimental: Extracorporeal Shock Wave Therapy group<br>This group received the same treatment as the control group plus Extracorporeal Shock Wave Therapy (The DermaPACE® System, SANUWAVE Health Inc., USA) with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period. | Device: Extracorporal Shock Wave Therapy<br>* Acoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance | Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome. | 6 months from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar pruritus | Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome. | 6 months from inclusion | 
| Scar pain | Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome. | 6 months from inclusion |