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NCT Number: NCT04187586

Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

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.

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Key information

Conditions

Burn Scar Burns Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shock Wave Therapy

Other

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.

Primary outcomes

  1. scar thickness

    Time frame: 6 weeks

    hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Collaborators

  • Hallym University

Registry information

Official study title

Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics: A Retrospective Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2019
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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