Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

Completed

• Conditions: Burn Scar
• Interventions: Other: Extracorporeal shock wave therapy

• Registration Number: NCT04187586
• Lead Sponsor: Hangang Sacred Heart Hospital

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2019-12-10
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy group	Extracorporeal shock wave therapy	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.

Primary Outcome Measures

Name	Time	Method
scar thickness	6 weeks	hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).

Secondary Outcome Measures

Name	Time	Method
scar transepidermal water loss(TEWL)	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.
scar erythema	6 weeks	pigementation and erythema check using Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany). The higher values indicating a darker and redder skin.
Sebum	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	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.

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Yeong-deungpo-Dong, Korea, Republic of