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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Cicatrix, Hypertrophic

Treatments: Device: Extracorporal Shock Wave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04558944

PR(ATR)398/2016

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Extracorporeal Shock Wave Therapy group

Experimental group

Description:

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.

Treatment:

Device: Extracorporal Shock Wave Therapy