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Clinical Trials/NCT04558944
NCT04558944
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country40 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cicatrix, Hypertrophic
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
40
Locations
1
Primary Endpoint
Scar appearance
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
February 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

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

  • Scar pruritus(6 months from inclusion)
  • Scar pain(6 months from inclusion)

Study Sites (1)

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