Clinical trial NCT03134053: Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Official title: Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophy; Scar
Keywords: hypertrophy scar
burn
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change from baseline thick of scar
timeFrame: immediately post intervention, 1 month after, and 3 months
Secondary outcomes:
measure: change from baseline Modified Vancouver Scar Scale
timeFrame: immediately post intervention, 1 month after, and 3 months
measure: change from baseline Visual analogue scores (VAS)
timeFrame: immediately post intervention, 1 month after, and 3 months
measure: change from baseline skin color
timeFrame: immediately post intervention, 1 month after, and 3 months
measure: change from baseline Patient Scar Assessment Scale (POSAS)
timeFrame: immediately post intervention, 1 month after, and 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References: