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Effect of Extracorporeal Shock Waves on Hypertrophy Scar

M

Mackay Memorial Hospital

Status

Unknown

Conditions

Hypertrophy; Scar

Treatments

Other: massage
Device: extracorporeal shock-wave

Study type

Interventional

Funder types

Other

Identifiers

NCT03134053
16MMHIS025e

Details and patient eligibility

About

Assess the effect of extracorporeal shock waves on hypertrophy scar

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

extracorporeal shock-wave
Experimental group
Treatment:
Device: extracorporeal shock-wave
massage
Sham Comparator group
Treatment:
Other: massage

Trial contacts and locations

1

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Central trial contact

Li-Ru Chen, MD

Data sourced from clinicaltrials.gov

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