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

Primary Purpose

Cicatrix, Hypertrophic

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Extracorporal Shock Wave Therapy
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix, Hypertrophic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jorge Aguilera Sáez

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Extracorporeal Shock Wave Therapy group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2020
Last Updated
September 29, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04558944
Brief Title
The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars
Official Title
Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Hypertrophic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Arm Title
Extracorporeal Shock Wave Therapy group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Extracorporal Shock Wave Therapy
Intervention Description
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 Outcome Measure Information:
Title
Scar appearance
Description
Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.
Time Frame
6 months from inclusion
Secondary Outcome Measure Information:
Title
Scar pruritus
Description
Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Time Frame
6 months from inclusion
Title
Scar pain
Description
Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Time Frame
6 months from inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jorge Aguilera Sáez
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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