Wound HealingNCT07548593
Plasma Therapy for Scar Management
An observational study of Wound Healing, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard scar care is effective and safe for treating various types of scars, including hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, and post-traumatic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing
- What is being tested?
- Plasma Device
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be recruited from patients presenting with various types of scars (hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, post-traumatic scars, post-acne scars) at the burn units, plastic surgery departments, or dermatology departments of 10 participating tertiary hospitals across China. Eligible participants are those who require scar management and meet the inclusion criteria. Patients in the plasma device group will be enrolled prospectively from those receiving standard scar care plus plasma device therapy as part of their routine clinical care. Control group participants will be derived from either: (1) concurrent patients receiving standard scar care alone at the same centers, or (2) retrospectively identified patients from medical records who received standard scar care without plasma therapy. Propensity score matching will be applied to balance baseline characteristics between the two groups. No special restrictions on gender,
Who may be able to join
- Clinical diagnosis of scar requiring therapeutic intervention, including but not limited to hypertrophic scar, keloid, atrophic scar, postoperative linear scar, burn scar, post-traumatic scar, or post-acne scar.
- Scar duration ≥ 3 months, in stable or proliferative phase.
- Age ≥ 12 years (for minors under 18 years, informed consent must be provided by a parent or legal guardian).
- Stable vital signs and able to tolerate scar treatment.
- Understand and willing to participate and able to provide signed informed consent.
Who cannot join
- Active infection, ulceration, or malignant tumor involving the scar area. Severe uncontrolled systemic disease or major organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder that prevents compliance with treatment.
- Presence of diseases (malignant tumor, autoimmune disease) or use of medications (high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect scar healing or assessment.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
- Pregnancy or breastfeeding.
- Previous treatment of the scar area (e.g., laser, injection, surgery) without a washout period of ≥3 months.
About this study
Official title: A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for the Treatment of Hypertrophic Scars, Keloids, Atrophic Scars, Postoperative Scars, and Burn Scars
This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard scar care is effective and safe for treating various types of scars, including hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, and post-traumatic scars. A total of 400 patients receiving standard scar care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 400 matched patients who received standard scar care alone. The main outcomes include change in Vancouver Scar Scale (VSS) score, pruritus relief, pain relief, scar thickness reduction, patient satisfaction, recurrence rate at 6 months, and any side effects. Patients will be followed for up to 6 months after treatment completion.
- Conditions
- Wound Healing
- Being tested
- Plasma Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma DeviceDevice
Cold atmospheric plasma device used for non-contact scar treatment. The device generates low-temperature plasma that modulates fibroblast proliferation, promotes collagen remodeling, reduces inflammation, and improves local microcirculation.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Device Group | Patients receiving standard scar care (silicone gel, pressure therapy, scar cream, etc.) plus plasma device therapy. The plasma device is applied non-contact to the scar area at a distance of 5-10 mm, with power set to low/medium mode according to scar type. Treatment duration: 5-10 seconds per cm², total not exceeding 15 minutes per session. Frequency: once every 2 weeks, total 4-6 sessions as one course. After each session, repair dressing or antibiotic ointment is applied. Receives: Device: Plasma Device | |
| Conventional Treatment Group | Patients receiving standard scar care alone, including silicone gel, pressure therapy, scar cream, etc., without plasma device therapy. Participants may be enrolled concurrently (not receiving plasma device) or identified retrospectively from medical records. Propensity score matching will be used to control for confounding factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vancouver Scar Scale (VSS) Score
The Vancouver Scar Scale (VSS) assesses four parameters: vascularity (0-3), pigmentation (0-3), pliability (0-5), and height (0-3). Total score ranges from 0 to 15, with higher scores indicating more severe scarring. The primary outcome is the change from baseline in total VSS score at 1 month after completion of treatment (Week 12).
Measured: Baseline to 1 month after treatment completion (Week 12)
Secondary outcomes (5)
Change in Pruritus Score
Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch.
Measured: Baseline to Week 12, Month 6
Change in Pain Score
Visual Analog Scale (VAS, 0-10) for pain severity, with 0 = no pain and 10 = worst possible pain.
Measured: Baseline to Week 12, Month 6
Change in Scar Thickness
Measured at the thickest point of the scar using high-frequency ultrasound or Vernier caliper.
Measured: Baseline to Week 12, Month 6
Patient Satisfaction
ssessed using a 5-point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) at 6 months after treatment completion.
Measured: Month 6
Recurrence Rate
Proportion of participants experiencing scar re-thickening or symptom recurrence within 6 months after treatment completion.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548593
- Sponsor's protocol ID
- SYSU-PLASMA-SCAR-2026-01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for the Treatment of Hypertrophic Scars, Keloids, Atrophic Scars, Postoperative Scars, and Burn Scars
- ClinicalTrials.gov ID
- NCT07548593
- Acronym / sponsor ID
- SYSU-PLASMA-SCAR-2026-01
- Conditions
- Wound Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard scar care is effective and safe for treating various types of scars, including hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, and post-traumatic scars. A total of 400 patients receiving standard scar care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 400 matched patients who received standard scar care alone. The main outcomes include change in Vancouver Scar Scale (VSS) score, pruritus relief, pain relief, scar thickness reduction, patient satisfaction, recurrence rate at 6 months, and any side effects. Patients will be followed for up to 6 months after treatment completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma Device Group | – | Device: Plasma DevicePatients receiving standard scar care (silicone gel, pressure therapy, scar cream, etc.) plus plasma device therapy. The plasma device is applied non-contact to the scar area at a distance of 5-10 mm, with power set to low/medium mode according to scar type. Treatment duration: 5-10 seconds per cm², total not exceeding 15 minutes per session. Frequency: once every 2 weeks, total 4-6 sessions as one course. After each session, repair dressing or antibiotic ointment is applied. |
| Conventional Treatment Group | – | –Patients receiving standard scar care alone, including silicone gel, pressure therapy, scar cream, etc., without plasma device therapy. Participants may be enrolled concurrently (not receiving plasma device) or identified retrospectively from medical records. Propensity score matching will be used to control for confounding factors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited from patients presenting with various types of scars (hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, post-traumatic scars, post-acne scars) at the burn units, plastic surgery departments, or dermatology departments of 10 participating tertiary hospitals across China. Eligible participants are those who require scar management and meet the inclusion criteria. Patients in the plasma device group will be enrolled prospectively from those receiving standard scar care plus plasma device therapy as part of their routine clinical care. Control group participants will be derived from either: (1) concurrent patients receiving standard scar care alone at the same centers, or (2) retrospectively identified patients from medical records who received standard scar care without plasma therapy. Propensity score matching will be applied to balance baseline characteristics between the two groups. No special restrictions on gender,
Key inclusion criteria (5 listed)
- Clinical diagnosis of scar requiring therapeutic intervention, including but not limited to hypertrophic scar, keloid, atrophic scar, postoperative linear scar, burn scar, post-traumatic scar, or post-acne scar.
- Scar duration ≥ 3 months, in stable or proliferative phase.
- Age ≥ 12 years (for minors under 18 years, informed consent must be provided by a parent or legal guardian).
- Stable vital signs and able to tolerate scar treatment.
- Understand and willing to participate and able to provide signed informed consent.
Key exclusion criteria (6 listed)
- Active infection, ulceration, or malignant tumor involving the scar area. Severe uncontrolled systemic disease or major organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder that prevents compliance with treatment.
- Presence of diseases (malignant tumor, autoimmune disease) or use of medications (high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect scar healing or assessment.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Plasma DeviceCold atmospheric plasma device used for non-contact scar treatment. The device generates low-temperature plasma that modulates fibroblast proliferation, promotes collagen remodeling, reduces inflammation, and improves local microcirculation. | Device | Plasma Device Group |
Primary outcome
Change in Vancouver Scar Scale (VSS) Score
Time frame: Baseline to 1 month after treatment completion (Week 12)
The Vancouver Scar Scale (VSS) assesses four parameters: vascularity (0-3), pigmentation (0-3), pliability (0-5), and height (0-3). Total score ranges from 0 to 15, with higher scores indicating more severe scarring. The primary outcome is the change from baseline in total VSS score at 1 month after completion of treatment (Week 12).
5 secondary outcomes
Change in Pruritus Score
Time frame: Baseline to Week 12, Month 6
Change in Pain Score
Time frame: Baseline to Week 12, Month 6
Change in Scar Thickness
Time frame: Baseline to Week 12, Month 6
Patient Satisfaction
Time frame: Month 6
Recurrence Rate
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing, run by First Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Vancouver Scar Scale (VSS) Score (time frame: Baseline to 1 month after treatment completion (Week 12)). 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 27 Apr 2026.