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Trial record 42 of 137 for:    Recruiting, Not yet recruiting, Available Studies | "Burns"

CO2 Laser Phototherapy for Management of Mature Burn Scars

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ClinicalTrials.gov Identifier: NCT03197649
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
University of California, Davis

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 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.
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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197649


Contacts
Contact: Lynda Painting 916-453-5085 lpainting@ucdavis.edu
Contact: Pirko Maguina, MD 916-453-2050 pmaguina@ucdavis.edu

Locations
United States, California
Shriners Hospitals for Children Recruiting
Sacramento, California, United States, 95817
Contact: Lynda Painting    916-453-5085    lpainting@ucdavis.edu   
Contact: Katrina Falwell, RN    916-453-2134    kafalwell@ucdavis.edu   
Principal Investigator: Pirko Maguina, MD         
Sponsors and Collaborators
University of California, Davis
Shriners Hospitals for Children
Investigators
Principal Investigator: Pirko Maguina, MD UC Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03197649     History of Changes
Other Study ID Numbers: 950482
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Burns
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes