Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

Overview

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics. Thus, this study aimed to ascertain the effects ESWT on burn scars. The investigators retrospectively reviewed burn patients who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis between January 2012 and September 2019.

Full Title of Study: “Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics: A Retrospective Study”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: December 12, 2019

Detailed Description

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics. Thus, this study aimed to ascertain the effects ESWT on burn scars. The investigators retrospectively reviewed burn patients who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis between January 2012 and September 2019. The ESWT group (n=17) received shock waves with low-energy flux density (0.05-0.30 mJ/mm2). The interval between treatments is a 1-week. The ESWT group also received standard treatment. The control group (n=18) only received standard treatment. We reviewed skin characteristics before and after 6 treatment sessions for both groups. The investigators checked skin charateristics(erythema, transepidermal water loss, sebum level, and elasticity). The investigators expect that ESWT is effective for significantly improving burn-associated scar characteristics and may be used for managing burn patients.

Interventions

• Other: Extracorporeal shock wave therapy
  • ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 6 sessions.

Arms, Groups and Cohorts

• Extracorporeal shock wave therapy group
  • The ESWT group received shock waves with low-energy flux density (0.05-0.30 mJ/mm2). The interval between treatments is a 1-week. To evaluate the effect of ESWT, we reviewed the skin test results (thickness, melanin, erythema, TEWL, sebum, and skin elasticity levels) immediately before ESWT and immediately after the sixth session. And also the ESWT group received the standard treatment, which involved medication, scar lubrication, burn rehabilitation massage therapy, and physical therapy.
• conventional therapy without extracorporeal shock wave therapy
  • Conventional therapy group received the standard treatment, which involved medication, scar lubrication, burn rehabilitation massage therapy, and physical therapy.

Clinical Trial Outcome Measures

Primary Measures

• scar thickness
  • Time Frame: 6 weeks
  • hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).

Secondary Measures

• scar erythema
  • Time Frame: 6 weeks
  • pigementation and erythema check using Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany). The higher values indicating a darker and redder skin.
• scar transepidermal water loss(TEWL)
  • Time Frame: 6 weeks
  • TEWL measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. The higher values indicating a skin dryness.
• Sebum
  • Time Frame: 6 weeks
  • Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in mg/cm2.
• Elasticity
  • Time Frame: 6 weeks
  • Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin’s distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. The higher values present the higher elasticity.

Participating in This Clinical Trial

Inclusion Criteria

• a retrospective review of 35 patients who had undergone STSG between January 2012 and September 2019 – limited to the upper extremities(the upper arm, forearm, and hand) – the scars which undergone STSG with same artificial dermis using Matriderm® (MeSkin Solution Dr. Suwelack AG, Billerbeck, Germany) Exclusion Criteria:

• not evaluated serial assessments – below 18 years age

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Investigator Details

• Lead Sponsor
  • Hangang Sacred Heart Hospital
• Collaborator
  • Hallym University
• Provider of Information About this Clinical Study
  • Sponsor

References

Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124.

Joo SY, Cho YS, Seo CH. The clinical utility of extracorporeal shock wave therapy for burn pruritus: A prospective, randomized, single-blind study. Burns. 2018 May;44(3):612-619. doi: 10.1016/j.burns.2017.09.014. Epub 2017 Oct 10.

Cho YS, Joo SY, Cui H, Cho SR, Yim H, Seo CH. Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study. Medicine (Baltimore). 2016 Aug;95(32):e4575. doi: 10.1097/MD.0000000000004575.