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Completed

NCT Number: NCT04769089

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.

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Key information

Conditions

Hypertrophic Scar Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Control

Other

One area will be randomized to receive no laser treatment.

Primary outcomes

  1. Effectiveness of laser treatments

    Time frame: 4-6 weeks post treatment

    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)

Secondary outcomes

  1. Improvement of symptoms

    Time frame: 4-6 weeks post treatment

    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.

Sponsors and collaborators

Lead sponsor

The Metis Foundation

Other

Collaborators

  • United States Army Institute of Surgical Research

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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