Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Assess the effect of extracorporeal shock waves on hypertrophy scar

Study Overview

• Status: Unknown
• Conditions: Hypertrophy; Scar
• Intervention / Treatment: Device: extracorporeal shock-wave; Other: massage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Ru Chen, MD; Phone Number: 886-2-2543-3535; Email: gracealex168@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital
    • Contact: Li-Ru Chen, MD; Email: gracealex168@gmail.com
    • Principal Investigator: Li-Ru Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extracorporeal shock-wave	Device: extracorporeal shock-wave; to treat painful and retracting scars
Sham Comparator: massage	Other: massage; to treat painful and retracting scars

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change from baseline Visual analogue scores (VAS)	Visual analogue scores (VAS) for pain	immediately post intervention, 1 month after, and 3 months
change from baseline skin color	DermaLab Combo series for skin color	immediately post intervention, 1 month after, and 3 months
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: burn; hypertrophy scar
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 16MMHIS025e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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