CO2 Laser Phototherapy for Management of Mature Burn Scars

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT03197649

Collaborator

Shriners Hospitals for Children (Other)

Enrollment

Location

Arms

23.2

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Burn Scar	Procedure: Laser phototherapy treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

Participant is blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 22, 2017

Actual Primary Completion Date :

Apr 29, 2019

Actual Study Completion Date :

Apr 29, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in scar assessment evaluation [Prior to initial treatment and no sooner than 3 months following last treatment]
Patient and Observer Scar Assessment Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shriners Hospitals for Children	Sacramento	California	United States	95817

Sponsors and Collaborators

University of California, Davis
Shriners Hospitals for Children

Investigators

Principal Investigator: Pirko Maguina, MD, UC Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT03197649

Other Study ID Numbers:

950482

First Posted:

Jun 23, 2017

Last Update Posted:

Jul 16, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cicatrix

Burns

Study Results

No Results Posted as of Jul 16, 2020