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

NCT04558944 | Completed

• 1 other identifier: PR(ATR)398/2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cicatrix, Hypertrophic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scar pruritus

  6 months from inclusion

• Scar pain

  6 months from inclusion

Study Arms (2)

Control group

NO INTERVENTION

This group received pain and pruritus medication as needed, received the usual physical therapy as per the protocol of our burn unit, as well as compression garments, silicone sheets and gels and moisturizing cream twice a day. Additionally, the patients were advice on reducing sun exposure and applying +50SPF sunblock on a daily basis.

Extracorporeal Shock Wave Therapy group

EXPERIMENTAL

This group received the same treatment as the control group plus Extracorporeal Shock Wave Therapy (The DermaPACE® System, SANUWAVE Health Inc., USA) 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.

Device: Extracorporal Shock Wave Therapy

Interventions

Extracorporal Shock Wave Therapy DEVICE

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.

Extracorporeal Shock Wave Therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Jorge Aguilera Sáez

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two randomized groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group (ESWT) received the standard treatment and treatment of postburn scars with ESWT 512 impulses of o.15mJ/mm 2 in each session, twice per week for 4 weeks.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: January 1, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)