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

NCT02861248 | Completed

• 1 other identifier: Plasma-1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cicatrix

Keywords

Burn Scar; Micro-plasma Radiofrequency Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 6 months after final treatment

Secondary Outcomes (1)

• Complications

  From baseline to 6 months after final treatment

Study Arms (1)

Laser treatment

EXPERIMENTAL

Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.

Procedure: Fractional micro-plasma radiofrequency treatment

Interventions

Fractional micro-plasma radiofrequency treatment PROCEDURE

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.

Laser treatment

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with ≥1-year-old non-hypertrophic burn scars

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Laser division of Plastic Surgery Department, Shanghai 9th people's hospital

Shanghai, 200011, China

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 10, 2016
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CN (1)