CO2 Laser Phototherapy for Management of Mature Burn Scars

NCT ID: NCT03197649

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2019-04-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Burn Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant is blinded

Study Groups

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Control

No laser phototherapy treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Laser phototherapy treatment

Laser phototherapy treatment administered in OR

Group Type EXPERIMENTAL

Laser phototherapy treatment

Intervention Type PROCEDURE

Laser phototherapy treatment administered in OR

Interventions

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Laser phototherapy treatment

Laser phototherapy treatment administered in OR

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pirko Maguina, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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Shriners Hospitals for Children

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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950482

Identifier Type: -

Identifier Source: org_study_id

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