Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187586
• Other study ID #: HangangSHH-9
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: December 2019
• Source: Hangang Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Hallym University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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). pii: E124. doi: 10.3390/ijms19010124. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar thickness	hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).	6 weeks
Secondary	scar erythema	pigementation and erythema check using Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany). The higher values indicating a darker and redder skin.	6 weeks
Secondary	scar transepidermal water loss(TEWL)	TEWL measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. The higher values indicating a skin dryness.	6 weeks
Secondary	Sebum	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.	6 weeks
Secondary	Elasticity	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.	6 weeks