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

NCT04769089 | Completed

• 1 other identifier: M-10590
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of symptoms

  4-6 weeks post treatment

Study Arms (4)

Pulse Dye Laser

EXPERIMENTAL

Treatment with PDL alone.

Procedure: Treatment with Pulse Dye Laser

CO2 Laser

EXPERIMENTAL

Treatment with CO2 alone.

Procedure: Treatment with CO2 Laser

Combination

EXPERIMENTAL

Treatment with both PDL and CO2 laser.

Procedure: Treatment with combination of pulse dye laser and CO2 laser.

No treatment

ACTIVE COMPARATOR

No laser treatment.

Other: Control

Interventions

Treatment with Pulse Dye Laser PROCEDURE

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.

Pulse Dye Laser

Treatment with CO2 Laser PROCEDURE

CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.

CO2 Laser

Treatment with combination of pulse dye laser and CO2 laser. PROCEDURE

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.

Combination

Control OTHER

One area will be randomized to receive no laser treatment.

No treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Timing: There has been a minimum of 1 month after burn closure
• The subject is at least 18 years of age and not older than 65.
• Able and willing to provide verbal and written consent.

You may not qualify if:

• Active infection in experimental area
• Use of isotretinoin (Accutane) in last six months
• Life or limb-threatening injury/disease
• Prior history of non-compliance with medical regimes
• Active drug use/abuse
• Active psychiatric illness except depression (unless being treated for suicidal intentions)
• Pregnancy
• 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.
• Prior PDL or other laser treatment of the study area.
• Patient unable to tolerate laser procedure.

Sponsors & Collaborators

• The Metis Foundation: lead
• United States Army Institute of Surgical Research: collaborator

Study Sites (1)

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• 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.

  PMID: 35943226 DERIVED

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Therapeutics; Lasers, Gas

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Rodney Chan, MD

  Metis Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 24, 2021
• Study Start: December 19, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)