Plasma Therapy for Scar Management

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Wound Healing

Treatments: Device: Plasma Device

Study type: Observational

Funder types: Other

Identifiers

NCT07548593

SYSU-PLASMA-SCAR-2026-01

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

800 participants in 2 patient groups

Plasma Device Group

Description:

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.

Treatment:

Device: Plasma Device

Conventional Treatment Group

Description:

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.