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

Burn Injury Clinical Trial

Official title:

Laser Therapy on Burned Skin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947449
• Other study ID #: STU-2021-0241
• Status: Recruiting
• Start date: July 29, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of Texas Southwestern Medical Center
• Contact: whitley Atkins, PhD
• Phone: 214-345-4623
• Email: whitleyatkins[@]texashealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin blood flow	Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.	Upwards to 6 months after the final laser treatment