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Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Primary Purpose

Hypertrophy; Scar

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
extracorporeal shock-wave
massage
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophy; Scar focused on measuring hypertrophy scar, burn

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

extracorporeal shock-wave

massage

Arm Description

Outcomes

Primary Outcome Measures

change from baseline thick of scar
sonography for thick of scar

Secondary Outcome Measures

change from baseline Modified Vancouver Scar Scale
questionnaires of Modified Vancouver Scar Scale for scar measure
change from baseline Visual analogue scores (VAS)
Visual analogue scores (VAS) for pain
change from baseline skin color
DermaLab Combo series for skin color
change from baseline Patient Scar Assessment Scale (POSAS)
questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure

Full Information

First Posted
April 19, 2017
Last Updated
August 29, 2017
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03134053
Brief Title
Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Official Title
Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Assess the effect of extracorporeal shock waves on hypertrophy scar
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy; Scar
Keywords
hypertrophy scar, burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
extracorporeal shock-wave
Arm Type
Experimental
Arm Title
massage
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
extracorporeal shock-wave
Intervention Description
to treat painful and retracting scars
Intervention Type
Other
Intervention Name(s)
massage
Intervention Description
to treat painful and retracting scars
Primary Outcome Measure Information:
Title
change from baseline thick of scar
Description
sonography for thick of scar
Time Frame
immediately post intervention, 1 month after, and 3 months
Secondary Outcome Measure Information:
Title
change from baseline Modified Vancouver Scar Scale
Description
questionnaires of Modified Vancouver Scar Scale for scar measure
Time Frame
immediately post intervention, 1 month after, and 3 months
Title
change from baseline Visual analogue scores (VAS)
Description
Visual analogue scores (VAS) for pain
Time Frame
immediately post intervention, 1 month after, and 3 months
Title
change from baseline skin color
Description
DermaLab Combo series for skin color
Time Frame
immediately post intervention, 1 month after, and 3 months
Title
change from baseline Patient Scar Assessment Scale (POSAS)
Description
questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure
Time Frame
immediately post intervention, 1 month after, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 18 ~ 65 years old; at least 4 weeks since onset of onset of wound; healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks the most important of all, read and signed the inform concern of this study. Exclusion Criteria: patients with open wound; oxygen dependent having evidence of cognitive deficit; having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT; patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Ru Chen, MD
Phone
886-2-2543-3535
Email
gracealex168@gmail.com
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Ru Chen, MD
Email
gracealex168@gmail.com
First Name & Middle Initial & Last Name & Degree
Li-Ru Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Extracorporeal Shock Waves on Hypertrophy Scar

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