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

Not Applicable

Completed

• Conditions: Cicatrix, Hypertrophic
• Interventions: Device: Extracorporal Shock Wave Therapy

• Registration Number: NCT04558944
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal Shock Wave Therapy group	Extracorporal Shock Wave Therapy	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.

Primary Outcome Measures

Name	Time	Method
Scar appearance	6 months from inclusion	Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Scar pruritus	6 months from inclusion	Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Scar pain	6 months from inclusion	Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Jorge Aguilera Sáez; 🇪🇸 Barcelona, Spain