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
Qualifiers
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 design
Treatments tested in this trial
- Plasma Device
Treatment groups
800 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov