Plasma Therapy for Scar Management

NCT07548593 | Not Yet Recruiting

• 1 other identifier: SYSU-PLASMA-SCAR-2026-01
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to 1 month after treatment completion (Week 12)

Secondary Outcomes (5)

• Change in Pruritus Score

  Baseline to Week 12, Month 6

• Change in Pain Score

  Baseline to Week 12, Month 6

• Change in Scar Thickness

  Baseline to Week 12, Month 6

• Patient Satisfaction

  Month 6

• Recurrence Rate

  Month 6

Study Arms (2)

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.

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.

Interventions

Plasma Device DEVICE

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.

Plasma Device Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04