Plasma Therapy for Scar Management

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Device: Plasma Device

• Study Type: Observational
• Enrollment (Estimated): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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,

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pruritus Score	Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch.	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.	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.	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.	Month 6
Recurrence Rate	Proportion of participants experiencing scar re-thickening or symptom recurrence within 6 months after treatment completion.	Month 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYSU-PLASMA-SCAR-2026-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No