Hypertrophic ScarsNegative pressNCT06690749
Using Skin Blood Flow to Measure the Effect of Different Doses of Negative Pressure Therapy
A study testing Negative pressure therapy, NPT in people with Hypertrophic Scars, run by Asia University at 1 site in Taiwan.
Trial summary
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF. However, it is unclear what dosage of NPT is most effective in treating scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Negative pressure therapy, NPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2022to 11 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Wounds must have been present for at least 21 days.
- The participants were in the proliferation or remodeling phase.
- Within nine months of skin injury.
Who cannot join
- Incomplete wound healing.
- leakage of tissue fluid.
- Participants of the Edema.
- The other short-term treatment plans (pressure garments, radiotherapy, steroids, and cryotherapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Negative Pressure Therapy on Skin Blood Flow Responses in the Scar
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF. However, it is unclear what dosage of NPT is most effective in treating scars.
This study compared NPT dosages of -105 mmHg, -125 mmHg, and -145 mmHg to assess the impact of NPT treatment on SBF in scar tissue and the correlation of NPT. If participants experience any symptoms of discomfort, NPT can be discontinued immediately.
Read more
36 scarred subjects were recruited to assess the efficacy of various NPT interventions. SBF applications are defined as perfusion levels instantly affecting NPT, and termination is defined as SBF after NPT.
The study runs from May 11, 2022, to May 11, 2023, at Asia University Hospital.
This study was funded by the National Science and Technology Council, Taiwan (NSTC 112-2221-E-468-004)
The main contact was Chi-Wen Lung, the person in charge of a college or university department of Product Design, Asia University, Taichung 413305, Taiwan.Email address: cwlung@asia.edu.tw
Read the detailed description
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF.
This study's hypothesis was that NPT can enhance SBF in scar tissue and that the specific NPT dose affects this effect. The purpose of this study was to confirm the different dosages of NPT applied to scar tissue by comparing the blood flow before and after the effects of different NPT dosages. This will also contribute to the emerging field of scar treatment and provide evidence-based recommendations.
All recruited participants were approached to participate in a research study investigating the effects of NPT in a double-blind, parallel-group study on scar healing. This study used three negative pressure changes at -105, -125 mmHg, and -145 mmHg at 10 min. The suction method created a negative pressure in the cup using an electronic negative-pressure device (Medi Pump TC-2000V; Anest Iwata Sparmax Co., Ltd., Taipei, Taiwan). A cup with an inner diameter of 45 mm and outer diameter of 53 mm was used for cupping therapy. Each side of the cup rim had a width of 4 mm; therefore, no pain was caused by the cup rim.
Pearson product-moment correlation analysis was used to determine the correlations between the SBF-Baseline, SBF-Application, and SBF-Termination factors.
- Conditions
- Hypertrophic Scars
- Being tested
- Negative pressure therapy, NPT
- Keywords
- Scar, Laser Doppler, Tensile stresses, Capillaries, Cupping
- Medical subject headings
- Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure therapy, NPTDevice
Also called -105 mmHg NPT, -125 mmHg NPT, -145 mmHg NPT
We designed the experiment based on current clinical cases involving negative pressure therapy (NPT) for wounds and related animal studies. In this study, we applied three levels of negative pressure: -105 mmHg, -125 mmHg, and -145 mmHg, each for 10 minutes.
The -125 mmHg dosage was chosen based on findings from a previous study. Similar studies that utilized increments and decrements of 20 mmHg informed our research.
Moreover, to prevent any damage to new capillaries, we established a base dosage of -125 mmHg and refrained from using negative pressure levels exceeding -150 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure therapy dosage | Experimental | A negative pressure value gap of 20mmHg was used between the each groups. Receives: Device: Negative pressure therapy, NPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Blood Flow
The skin blood flow (SBF) before negative pressure therapy (NPT) recorded from 30 seconds to 1 minute was defined as the SBF-termination value.
The 0-30 seconds SBF before NPT was the baseline SBF-Baseline. The records of the calculated NPT value from 10 minutes to 10.5 min are defined as application value.
The record with 30 seconds to 1 minute after NPT is defined as the SBF-termination value. The evaluation standard is the 30-second average.
Measured: Three minutes before to three minutes after negative pressure treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start11 May 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies 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
- Sequential
- Model description
- The study design and setting sample were drawn from patients randomly assigned to one of three parallel groups, initially in a 1:1:1 ratio to invite the subject to receive either NPT dosage.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690749
- Sponsor's protocol ID
- CRREC-111-017
- Other IDs
- NSTC 112-2221-E-468-004
- Acronym
- Negative press
- Status last verified
- May 2022
- First submitted
- 5 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data values of the skin blood flow study result in the Clinical Study Report (CSR) will be provided to the submitting journal when the relevant journal publishes.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Negative Pressure Therapy on Skin Blood Flow Responses in the Scar
- ClinicalTrials.gov ID
- NCT06690749
- Acronym / sponsor ID
- Negative press / CRREC-111-017
- Conditions
- Hypertrophic Scars
- Keywords
- Scar, Laser Doppler, Tensile stresses, Capillaries, Cupping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 15 Nov 2024 (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.
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF. However, it is unclear what dosage of NPT is most effective in treating scars.
This study compared NPT dosages of -105 mmHg, -125 mmHg, and -145 mmHg to assess the impact of NPT treatment on SBF in scar tissue and the correlation of NPT. If participants experience any symptoms of discomfort, NPT can be discontinued immediately.
36 scarred subjects were recruited to assess the efficacy of various NPT interventions. SBF applications are defined as perfusion levels instantly affecting NPT, and termination is defined as SBF after NPT.
The study runs from May 11, 2022, to May 11, 2023, at Asia University Hospital.
This study was funded by the National Science and Technology Council, Taiwan (NSTC 112-2221-E-468-004)
The main contact was Chi-Wen Lung, the person in charge of a college or university department of Product Design, Asia University, Taichung 413305, Taiwan.Email address: cwlung@asia.edu.tw
Detailed description
Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF.
This study's hypothesis was that NPT can enhance SBF in scar tissue and that the specific NPT dose affects this effect. The purpose of this study was to confirm the different dosages of NPT applied to scar tissue by comparing the blood flow before and after the effects of different NPT dosages. This will also contribute to the emerging field of scar treatment and provide evidence-based recommendations.
All recruited participants were approached to participate in a research study investigating the effects of NPT in a double-blind, parallel-group study on scar healing. This study used three negative pressure changes at -105, -125 mmHg, and -145 mmHg at 10 min. The suction method created a negative pressure in the cup using an electronic negative-pressure device (Medi Pump TC-2000V; Anest Iwata Sparmax Co., Ltd., Taipei, Taiwan). A cup with an inner diameter of 45 mm and outer diameter of 53 mm was used for cupping therapy. Each side of the cup rim had a width of 4 mm; therefore, no pain was caused by the cup rim.
Pearson product-moment correlation analysis was used to determine the correlations between the SBF-Baseline, SBF-Application, and SBF-Termination factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design and setting sample were drawn from patients randomly assigned to one of three parallel groups, initially in a 1:1:1 ratio to invite the subject to receive either NPT dosage.
| Arm | Type | Receives |
|---|---|---|
| Negative pressure therapy dosage | Experimental | Device: Negative pressure therapy, NPTA negative pressure value gap of 20mmHg was used between the each groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older.
- Wounds must have been present for at least 21 days.
- The participants were in the proliferation or remodeling phase.
- Within nine months of skin injury.
Key exclusion criteria (4 listed)
- Incomplete wound healing.
- leakage of tissue fluid.
- Participants of the Edema.
- The other short-term treatment plans (pressure garments, radiotherapy, steroids, and cryotherapy).
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 |
|---|---|---|
| Negative pressure therapy, NPTAlso: -105 mmHg NPT, -125 mmHg NPT, -145 mmHg NPTWe designed the experiment based on current clinical cases involving negative pressure therapy (NPT) for wounds and related animal studies. In this study, we applied three levels of negative pressure: -105 mmHg, -125 mmHg, and -145 mmHg, each for 10 minutes. The -125 mmHg dosage was chosen based on findings from a previous study. Similar studies that utilized increments and decrements of 20 mmHg informed our research. Moreover, to prevent any damage to new capillaries, we established a base dosage of -125 mmHg and refrained from using negative pressure levels exceeding -150 mmHg. | Device | Negative pressure therapy dosage |
Primary outcome
Skin Blood Flow
Time frame: Three minutes before to three minutes after negative pressure treatment
The skin blood flow (SBF) before negative pressure therapy (NPT) recorded from 30 seconds to 1 minute was defined as the SBF-termination value. The 0-30 seconds SBF before NPT was the baseline SBF-Baseline. The records of the calculated NPT value from 10 minutes to 10.5 min are defined as application value. The record with 30 seconds to 1 minute after NPT is defined as the SBF-termination value. The evaluation standard is the 30-second average.
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 15 Nov 2024.
- Individual participant dataSharing planned: Undecided. The raw data values of the skin blood flow study result in the Clinical Study Report (CSR) will be provided to the submitting journal when the relevant journal publishes.
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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 Negative pressure therapy, NPT in people with Hypertrophic Scars, run by Asia University at 1 site in Taiwan.
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 4 inclusion and 4 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 15 Nov 2024. 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 Taiwan. 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?
Skin Blood Flow (time frame: Three minutes before to three minutes after negative pressure treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.