Effect of Extracorporeal Shock Waves on Hypertrophy Scar

NCT ID: NCT03134053

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-06-01

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.

Conditions

Hypertrophy; Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

extracorporeal shock-wave

Group Type: EXPERIMENTAL

extracorporeal shock-wave

Intervention Type: DEVICE

to treat painful and retracting scars

massage

Group Type: SHAM_COMPARATOR

massage

Intervention Type: OTHER

to treat painful and retracting scars

Interventions

extracorporeal shock-wave

to treat painful and retracting scars

Intervention Type: DEVICE

massage

to treat painful and retracting scars

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li-Ru Chen,MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Li-Ru Chen, MD

Role: CONTACT

gracealex168@gmail.com

886-2-2543-3535

Facility Contacts

Li-Ru Chen, MD

Role: primary

gracealex168@gmail.com

Other Identifiers

16MMHIS025e

Identifier Type: -

Identifier Source: org_study_id