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Not yet recruiting NCT07548593

Plasma Therapy for Scar Management: A Prospective Study

Conditions: Wound Healing

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Plasma Device
DEVICE
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.05.2026
Completion date
31.12.2026
Registry ID
NCT07548593
Source
clinicaltrials.gov
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