Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scar
• Intervention / Treatment: Procedure: Treatment with Pulse Dye Laser; Procedure: Treatment with CO2 Laser; Procedure: Treatment with combination of pulse dye laser and CO2 laser.; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • United States Army Institute of Surgical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.
2. Timing: There has been a minimum of 1 month after burn closure
3. The subject is at least 18 years of age and not older than 65.
4. Able and willing to provide verbal and written consent.

Exclusion Criteria:

1. Active infection in experimental area
2. Use of isotretinoin (Accutane) in last six months
3. Life or limb-threatening injury/disease
4. Prior history of non-compliance with medical regimes
5. Active drug use/abuse
6. Active psychiatric illness except depression (unless being treated for suicidal intentions)
7. Pregnancy
8. Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.
9. Prior PDL or other laser treatment of the study area.
10. Patient unable to tolerate laser procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulse Dye Laser; Treatment with PDL alone.	Procedure: Treatment with Pulse Dye Laser; Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.
Experimental: CO2 Laser; Treatment with CO2 alone.	Procedure: Treatment with CO2 Laser; CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
Experimental: Combination; Treatment with both PDL and CO2 laser.	Procedure: Treatment with combination of pulse dye laser and CO2 laser.; Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
Active Comparator: No treatment; No laser treatment.	Other: Control; One area will be randomized to receive no laser treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of laser treatments	Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS)	4-6 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms	To longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each patient and two observers (to increase score reliability) at each follow-up visit.	4-6 weeks post treatment

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Collaborators: United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Rodney Chan, MD, Metis Foundation

Publications and helpful links

General Publications

• Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
• Other Study ID Numbers: M-10590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes