Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Hypertrophy; Scar Clinical Trial

Official title:

Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03134053
• Other study ID #: 16MMHIS025e
• Status: Not yet recruiting
• Phase: N/A
• First received: April 19, 2017
• Last updated: August 29, 2017
• Start date: October 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2017
• Source: Mackay Memorial Hospital
• Contact: Li-Ru Chen, MD
• Phone: 886-2-2543-3535
• Email: gracealex168[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the effect of extracorporeal shock waves on hypertrophy scar

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 1, 2019
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophy
• Hypertrophy; Scar

Intervention

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

Other:
• massage
to treat painful and retracting scars

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline thick of scar	sonography for thick of scar	immediately post intervention, 1 month after, and 3 months
Secondary	change from baseline Modified Vancouver Scar Scale	questionnaires of Modified Vancouver Scar Scale for scar measure	immediately post intervention, 1 month after, and 3 months
Secondary	change from baseline Visual analogue scores (VAS)	Visual analogue scores (VAS) for pain	immediately post intervention, 1 month after, and 3 months
Secondary	change from baseline skin color	DermaLab Combo series for skin color	immediately post intervention, 1 month after, and 3 months
Secondary	change from baseline Patient Scar Assessment Scale (POSAS)	questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure	immediately post intervention, 1 month after, and 3 months