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

September 29, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Jorge Aguilera Sáez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months from inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months from inclusion
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.
6 months from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

February 15, 2019

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(ATR)398/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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