Burn ScarNCT04187586
Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics
An observational study of Burn Scar, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burn Scar
- What is being tested?
- Extracorporeal shock wave therapy
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2019to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- not evaluated serial assessments
- below 18 years age
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hangang Sacred Heart Hospital
Seoul, Yeong-deungpo-Dong, 150-719
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics: A Retrospective 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.
Read the 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.
- Conditions
- Burn Scar
- Being tested
- Extracorporeal shock wave therapy
- Keywords
- burns, rehabilitation, extracorporeal shock wave therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar thickness
hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).
Measured: 6 weeks
Secondary outcomes (4)
scar erythema
pigementation and erythema check using Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany). The higher values indicating a darker and redder skin.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Dec 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187586
- Sponsor's protocol ID
- HangangSHH-9
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29301325Joo 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.
PubMed 29029857Cho 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.
PubMed 27512886
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04187586
- Acronym / sponsor ID
- HangangSHH-9
- Conditions
- Burn Scar
- Keywords
- burns, rehabilitation, extracorporeal shock wave therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy group | – | Other: Extracorporeal shock wave therapyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- not evaluated serial assessments
- below 18 years age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapyESWT 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. | Other | Extracorporeal shock wave therapy group |
Primary outcome
scar thickness
Time frame: 6 weeks
hypertrophic scar thickness check using ultrasonic wave equipment (128 BW1 Medison, Korea).
4 secondary outcomes
scar erythema
Time frame: 6 weeks
scar transepidermal water loss(TEWL)
Time frame: 6 weeks
Sebum
Time frame: 6 weeks
Elasticity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 29301325Cui 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.
- Background: PubMed 29029857Joo 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.
- Background: PubMed 27512886Cho 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.
- Individual participant dataSharing planned: No
Related trials for Burn Scar
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingPhase 3
Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Scar, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar thickness (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.