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Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861248
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine

Brief Summary:
A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.

Condition or disease Intervention/treatment Phase
Cicatrix Procedure: Fractional micro-plasma radiofrequency treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Arm Intervention/treatment
Experimental: Laser treatment
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Procedure: 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.




Primary Outcome Measures :
  1. POSAS score [ Time Frame: 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 Outcome Measures :
  1. Complications [ Time Frame: From baseline to 6 months after final treatment ]
    Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861248


Locations
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China
Laser division of Plastic Surgery Department, Shanghai 9th people's hospital
Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Qing-FengLi Li,MD, M.D., Ph.D., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02861248    
Other Study ID Numbers: Plasma-1
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine:
Burn Scar
Micro-plasma Radiofrequency Therapy
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes