Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Overview

Assess the effect of extracorporeal shock waves on hypertrophy scar

Full Title of Study: “Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2017

Detailed Description

Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars. Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.

Interventions

  • Device: extracorporeal shock-wave
    • to treat painful and retracting scars
  • Other: massage
    • to treat painful and retracting scars

Arms, Groups and Cohorts

  • Experimental: extracorporeal shock-wave
  • Sham Comparator: massage

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline thick of scar
    • Time Frame: immediately post intervention, 1 month after, and 3 months
    • sonography for thick of scar

Secondary Measures

  • change from baseline Modified Vancouver Scar Scale
    • Time Frame: immediately post intervention, 1 month after, and 3 months
    • questionnaires of Modified Vancouver Scar Scale for scar measure
  • change from baseline Visual analogue scores (VAS)
    • Time Frame: immediately post intervention, 1 month after, and 3 months
    • Visual analogue scores (VAS) for pain
  • change from baseline skin color
    • Time Frame: immediately post intervention, 1 month after, and 3 months
    • DermaLab Combo series for skin color
  • change from baseline Patient Scar Assessment Scale (POSAS)
    • Time Frame: immediately post intervention, 1 month after, and 3 months
    • questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure

Participating in This Clinical Trial

Inclusion Criteria

1. aged between 18 ~ 65 years old; 2. at least 4 weeks since onset of onset of wound; 3. healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks 4. the most important of all, read and signed the inform concern of this study. Exclusion Criteria:

1. patients with open wound; 2. oxygen dependent 3. having evidence of cognitive deficit; 4. having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT; 5. patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mackay Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Li-Ru Chen,MD, MD – Mackay Memorial Hospital
  • Overall Contact(s)
    • Li-Ru Chen, MD, 886-2-2543-3535, gracealex168@gmail.com

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