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Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04947449
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Craig Crandall, University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.

Condition or disease Intervention/treatment
Burn Injury Device: fractional CO2 laser

Detailed Description:

This is a longitudinal study in which the effects of laser therapy on cutaneous vascular responses and sweating of the treated areas are assessed. Specifically, burn survivors who will undergo standard of care laser therapy to treat burn-related scars will perform whole-body heating and local heating procedures prior to the initiation of laser therapy, at an intermediate point during the laser therapy regimen, and upon conclusion of the laser therapy regimen.

For this pilot investigation a placebo will not be incorporated.

Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Therapy on Burned Skin
Actual Study Start Date : July 29, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Sweat


Intervention Details:
  • Device: fractional CO2 laser
    Standard of care laser treatment of burn-related injuries will be performed. This protocol assesses the effects of those treatments on skin blood flow and sweating responses.


Primary Outcome Measures :
  1. Skin blood flow [ Time Frame: Upwards to 6 months after the final laser treatment ]
    Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals who undergo laser treatment for burn injuries
Criteria

Inclusion Criteria:

  • 18-65 years old
  • Experience a severe burn injury that warrant laser therapy.
  • Free of any significant underlying medical problems based upon a detailed medical history and physical exam

Exclusion Criteria:

  • Known heart disease
  • Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
  • Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
  • Subject with a body mass index >35 kg/m2
  • Pregnant or planning to become pregnant within the subsequent 6 months.

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): NCT04947449


Contacts
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Contact: Josh Foster, PhD 214-345-6504 joshfoster@texashealth.org
Contact: Bonnie Orth, MS 214-345-4737 bonnieorth@texashealth.org

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Craig Crandall, PhD    214-345-4623      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Craig Crandall, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04947449    
Other Study ID Numbers: STU-2021-0241
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Craig Crandall, University of Texas Southwestern Medical Center:
laser treatment
laser therapy
skin blood flow
sweating
Additional relevant MeSH terms:
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Burns
Wounds and Injuries