Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
Primary Purpose
Cicatrix
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fractional micro-plasma radiofrequency treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix focused on measuring Burn Scar, Micro-plasma Radiofrequency Therapy
Eligibility Criteria
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.
Sites / Locations
- Laser division of Plastic Surgery Department, Shanghai 9th people's hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser treatment
Arm Description
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Outcomes
Primary Outcome Measures
POSAS score
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 Outcome Measures
Complications
Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported
Full Information
NCT ID
NCT02861248
First Posted
August 2, 2016
Last Updated
August 5, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02861248
Brief Title
Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
Burn Scar, Micro-plasma Radiofrequency Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser treatment
Arm Type
Experimental
Arm Description
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Intervention Type
Procedure
Intervention Name(s)
Fractional micro-plasma radiofrequency treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
POSAS score
Description
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.
Time Frame
From baseline to 6 months after final treatment
Secondary Outcome Measure Information:
Title
Complications
Description
Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported
Time Frame
From baseline to 6 months after final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Laser division of Plastic Surgery Department, Shanghai 9th people's hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
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