Cicatrix
Conditions
Keywords
Burn Scar, Micro-plasma Radiofrequency Therapy
Brief summary
A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.
Detailed description
Background: Laser therapy is an emerging, minimally invasive treatment for scars. Among the various techniques, fractional microplasma radiofrequency technology (FMRT) has proved to be effective for various types of scars and skin conditions such as rhytids, striae distensae, and hyperpigmentation. Method: A prospective clinical trial was conducted to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population. All patients underwent three to five treatment sessions at intervals of 8-16 weeks. The patient and observer scar assessment scales (POSAS) were use to evaluate changes in the burn scars before and after treatment. Intermediate and long-term adverse events were recorded for outcome analysis.
Interventions
PROCEDUREFractional micro-plasma radiofrequency treatment
After the patient's scars were subjected to a mild cleanser and 70% alcohol, a topical cream of 5% lidocaine hydrochloric acid (Beijing Ziguang Medication Manufacture Corporation Ltd, Beijing, China) was applied to the entire scar surface under occlusion for 60-90 min before treatment to achieve local anesthesia. Fractional micro-plasma radiofrequency treatment (Pixel RF, Accent XL; Alma Lasers, Caesarea, Israel) was applied using a roller tip at 50-80 watts. Three or four passes were made in different directions over each affected area. A high rolling speed of roughly 5 cm/s was manually controlled. This treatment was accompanied by an air cooler (Cryo 5; Zimmer, Warsaw, IN, USA) for pain control. All patients attended three to five treatment sessions at intervals of 8-16 weeks.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with ≥1-year-old non-hypertrophic burn scars
Exclusion criteria
* pregnancy or breastfeeding * history of hypertrophic scars or keloids * abnormal medical examination including routine blood count, liver and kidney functions and immune function * history of treatment including surgery, dermabrasion, laser treatment within the past 6 months * the presence of a cardiac pacemaker or other metallic implant near the treatment site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POSAS score | From baseline to 6 months after final treatment | The patient component of the POSAS contains six parameters that the patient scores: pain, itching, color, stiffness, thickness, relief. The physician (observer) component contains five parameters: vascularization, pigmentation, pliability, thickness, relief. Each parameter is scored from 1 to 10, with 1 indicating that the scar similar to normal skin and 10 indicating the worst situation imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | From baseline to 6 months after final treatment | Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported |
Countries
China
Outcome results
None listed