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Completed

NCT Number: NCT03197649

CO2 Laser Phototherapy for Management of Mature Burn Scars

Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

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Key information

Conditions

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospitals for Children

Sacramento, California, 95817, United States

About this study

Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars

The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 3 to 21
  • Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
  • Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
  • Entry into this study is open to pediatric patients of both genders.
  • Entry into this study is open to pediatric patients of all ethnic backgrounds.
  • Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test

Exclusion criteria

  • Patients with scars less than 2 years old
  • Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
  • Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.

Treatment and study plan

Laser phototherapy treatment

Procedure

Laser phototherapy treatment administered in OR

Primary outcomes

  1. Change in scar assessment evaluation

    Time frame: Prior to initial treatment and no sooner than 3 months following last treatment

    Patient and Observer Scar Assessment Scale

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Shriners Hospitals for Children

Registry information

Official study title

Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2017
Registry last updated
Jul 16, 2020

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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