Burn ScarNCT04340271
The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns
A study testing Extracorporeal shock wave therapy and conventional occupational therapy in people with Burn Scar, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective… 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 and conventional occupational therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2020to 31 May 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 years
- deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn
- less than 6 months since the onset of the burn injury
Who cannot join
- history of cancer
- fourth-degree burns (involving muscles, tendons, and bone injuries)
- musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases)
- pregnancy
- if there was potential for additional damage to the skin due to the use of ESWT and conventional occupational therapy
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: The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns of Upper Extremity : Controlled, Randomization, Double Bilind Study
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group.
Read the detailed description
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group. Each intervention was applied to the hypertrophic scars of upper extremities after autologous split-thickness skin grafting (STSG) using Materiderm for 4 weeks once per week. The ESWT group (n=18) 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) received sham stimulation with standard treatment. The investigators compared the skin quality of the ESWT and control groups. Participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. TEWL was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. 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 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.
- Conditions
- Burn Scar
- Being tested
- Extracorporeal shock wave therapy, conventional occupational therapy
- Keywords
- burn scar, extracorporeal shock wave therapy, skin characteristics
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 conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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 4 sessions.
conventional occupational therapyOther
Standard accupational therapy consist of range of motion exercise, strengthening exercises, and activities of daily living exercises
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy group | Experimental | Patients in the ESWT group were explained to select the most hypertrophic and retracting area for the treatment on dominant hand. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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 4 sessions. Receives: Other: Extracorporeal shock wave therapy; Other: conventional occupational therapy |
| sham stimulation group | Sham comparator | The same shock wave equipment used in the experimental group was used with a sham adapter that had the same shape but emitted no energy Receives: Other: conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar thickness
The thickness was measured with a ultrasonic wave equipment
Measured: 4 weeks
Secondary outcomes (5)
skin darkness
the degree of pigmentation and melanin level, the higher values indicating a darker(AU)
Measured: 4 weeks
skin reddness
the degree of erythema, the higher values indicating a redder skin(AU)
Measured: 4 weeks
skin dryness
evaluating the degree of water evaporation(g/h/m2). the higher values indicating a skin dryness
Measured: 4 weeks
sebum level
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: 4 weeks
Elasticity
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start15 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients' burn scars had re-epithelialized after split-thickness skin graft (STSG). We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their upper extremities, having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Young Joo, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340271
- Sponsor's protocol ID
- HangangSHH-10
- Status last verified
- Jun 2020
- First submitted
- 2 Apr 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29301325Saggini R, Saggini A, Spagnoli AM, Dodaj I, Cigna E, Maruccia M, Soda G, Bellomo RG, Scuderi N. Extracorporeal Shock Wave Therapy: An Emerging Treatment Modality for Retracting Scars of the Hands. Ultrasound Med Biol. 2016 Jan;42(1):185-95. doi: 10.1016/j.ultrasmedbio.2015.07.028. Epub 2015 Oct 9.
PubMed 26454624
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns of Upper Extremity : Controlled, Randomization, Double Bilind Study
- ClinicalTrials.gov ID
- NCT04340271
- Acronym / sponsor ID
- HangangSHH-10
- Conditions
- Burn Scar
- Keywords
- burn scar, extracorporeal shock wave therapy, skin characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 9 Apr 2020 (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.
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group.
Detailed description
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group. Each intervention was applied to the hypertrophic scars of upper extremities after autologous split-thickness skin grafting (STSG) using Materiderm for 4 weeks once per week. The ESWT group (n=18) 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) received sham stimulation with standard treatment. The investigators compared the skin quality of the ESWT and control groups. Participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. TEWL was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients' burn scars had re-epithelialized after split-thickness skin graft (STSG). We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their upper extremities, having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy group | Experimental | Other: Extracorporeal shock wave therapy, Other: conventional occupational therapyPatients in the ESWT group were explained to select the most hypertrophic and retracting area for the treatment on dominant hand. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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 4 sessions. |
| sham stimulation group | Sham comparator | Other: conventional occupational therapyThe same shock wave equipment used in the experimental group was used with a sham adapter that had the same shape but emitted no energy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥18 years
- deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn
- less than 6 months since the onset of the burn injury
Key exclusion criteria (5 listed)
- history of cancer
- fourth-degree burns (involving muscles, tendons, and bone injuries)
- musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases)
- pregnancy
- if there was potential for additional damage to the skin due to the use of ESWT and conventional occupational therapy
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 conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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 4 sessions. | Other | Extracorporeal shock wave therapy group |
| conventional occupational therapyStandard accupational therapy consist of range of motion exercise, strengthening exercises, and activities of daily living exercises | Other | Extracorporeal shock wave therapy group, sham stimulation group |
Primary outcome
scar thickness
Time frame: 4 weeks
The thickness was measured with a ultrasonic wave equipment
5 secondary outcomes
skin darkness
Time frame: 4 weeks
skin reddness
Time frame: 4 weeks
skin dryness
Time frame: 4 weeks
sebum level
Time frame: 4 weeks
Elasticity
Time frame: 4 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 4 Jun 2020.
- Results publication: 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.
- Results publication: PubMed 26454624Saggini R, Saggini A, Spagnoli AM, Dodaj I, Cigna E, Maruccia M, Soda G, Bellomo RG, Scuderi N. Extracorporeal Shock Wave Therapy: An Emerging Treatment Modality for Retracting Scars of the Hands. Ultrasound Med Biol. 2016 Jan;42(1):185-95. doi: 10.1016/j.ultrasmedbio.2015.07.028. Epub 2015 Oct 9.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Extracorporeal shock wave therapy and conventional occupational therapy in people with 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 5 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 4 Jun 2020. 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. Some participants in this study may receive a placebo. 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: 4 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 NCT04340271, which also lists 2 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 4 Jun 2020.