Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
NCT ID: NCT02861248
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2012-03-31
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laser treatment
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Fractional 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.
Interventions
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Fractional 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
10 Years
60 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Qing-FengLi Li,MD
M.D., Ph.D.
Locations
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Laser division of Plastic Surgery Department, Shanghai 9th people's hospital
Shanghai, , China
Countries
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Other Identifiers
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Plasma-1
Identifier Type: -
Identifier Source: org_study_id
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