The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars

Cicatrix, Hypertrophic Clinical Trial

Official title:

Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558944
• Other study ID #: PR(ATR)398/2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: September 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks.

The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.

Exclusion Criteria:

• Patients younger than 18 year.

• Pregnant women.

• Having a known skin condition (e.g. psoriasis, skin cancer etc.).

• Immunosuppression.

• Hemophilia .

• Matured scars.

• Scars located above the lungs, the bowels, the gonads or electronic implants.

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic

Intervention

Device:
• Extracorporal Shock Wave Therapy
Acoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.

Locations

Country	Name	City	State
Spain	Jorge Aguilera Sáez	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar appearance	Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.	6 months from inclusion
Secondary	Scar pruritus	Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.	6 months from inclusion
Secondary	Scar pain	Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.	6 months from inclusion