CO2 Laser Phototherapy for Management of Mature Burn Scars

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197649
• Other study ID #: 950482
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: April 29, 2019

Study information

• Verified date: July 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix

Intervention

Procedure:
• Laser phototherapy treatment
Laser phototherapy treatment administered in OR

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scar assessment evaluation	Patient and Observer Scar Assessment Scale	Prior to initial treatment and no sooner than 3 months following last treatment