CO2 Laser Phototherapy for Management of Mature Burn Scars

July 14, 2020 updated by: University of California, Davis

Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospitals for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No laser phototherapy treatment
Experimental: Laser phototherapy treatment
Laser phototherapy treatment administered in OR
Procedure: Laser phototherapy treatment
Laser phototherapy treatment administered in OR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to initial treatment and no sooner than 3 months following last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Pirko Maguina, MD, UC Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2017

Primary Completion (Actual)

April 29, 2019

Study Completion (Actual)

April 29, 2019

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 950482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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