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Completed

NCT Number: NCT04558944

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

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.

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Key information

Conditions

Cicatrix, Hypertrophic Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jorge Aguilera Sáez

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporal Shock Wave Therapy

Device

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.

Primary outcomes

  1. Scar appearance

    Time frame: 6 months from inclusion

    Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.

Secondary outcomes

  1. Scar pruritus

    Time frame: 6 months from inclusion

    Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.

  2. Scar pain

    Time frame: 6 months from inclusion

    Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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