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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197649
Other study ID # 950482
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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