Plasma Therapy for Scar Management
ConditionWound Healing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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,
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma Device
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.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Plasma Device Group1 intervention
Group B: Conventional Treatment Group0 interventions
Trial outcomes
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).
Time frame
Baseline to 1 month after treatment completion (Week 12)Secondary outcomes
1
Change in Pruritus Score
Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch.
Time frame
Baseline to Week 12, Month 62
Change in Pain Score
Visual Analog Scale (VAS, 0-10) for pain severity, with 0 = no pain and 10 = worst possible pain.
Time frame
Baseline to Week 12, Month 63
Change in Scar Thickness
Measured at the thickest point of the scar using high-frequency ultrasound or Vernier caliper.
Time frame
Baseline to Week 12, Month 64
Patient Satisfaction
ssessed using a 5-point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) at 6 months after treatment completion.
Time frame
Month 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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