Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

NCT04187586 | Completed DMC

• 1 other identifier: HangangSHH-9
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scar

Keywords

burns; rehabilitation; extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (1)

• scar thickness

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

  6 weeks

Secondary Outcomes (4)

• scar erythema

  6 weeks

• scar transepidermal water loss(TEWL)

  6 weeks

• Sebum

  6 weeks

• Elasticity

  6 weeks

Study Arms (2)

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.

Other: Extracorporeal shock wave 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.

Interventions

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.

Extracorporeal shock wave therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• not evaluated serial assessments
• below 18 years age

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead
• Hallym University: collaborator

Study Sites (1)

Hangang Sacred Heart Hospital

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

Location

Related Publications (3)

• 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.

  PMID: 29301325 BACKGROUND

• 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.

  PMID: 29029857 BACKGROUND

• 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.

  PMID: 27512886 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 10, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)