Clinical trial NCT04187586: Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics
Official title: Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Scar
Keywords: burns
rehabilitation
extracorporeal shock wave therapy
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University
First posted: 2019-12-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * This study was a retrospective review of 35 patients who had undergone STSG using Matriderm® (MeSkin Solution Dr. Suwelack AG, Billerbeck, Germany) between January 2012 and September 2019.
* The subjects who were admitted to the Department of Rehabilitation Medicine at Hangang Sacred Heart Hospital were enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: scar thickness
timeFrame: 6 weeks
Secondary outcomes:
measure: scar erythema
timeFrame: 6 weeks
measure: scar transepidermal water loss(TEWL)
timeFrame: 6 weeks
measure: Sebum
timeFrame: 6 weeks
measure: Elasticity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
state: Yeong-deungpo-Dong
Study officials:
References:
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):124. doi: 10.3390/ijms19010124.
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.
citation: 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.