Compression and CO2 Laser for Leg Wounds

Launched by NORTHWESTERN UNIVERSITY · Dec 12, 2019

Keywords

ClinConnect Summary

This study is exploring whether adding a fractional ablative CO2 laser (FACL) treatment to standard compression bandages helps healing results for leg wounds after skin removal surgery. It is a randomized, stepwise trial (called SMART), meaning participants are first assigned by chance to either compression bandages or standard dressings. After about 4 weeks, those who started with compression may be randomly assigned again to continue compression alone or to have the compression plus the laser treatment. The main question is how much the wound size changes from the start to 6 months.

To be eligible, adults 18 or older with a lower-leg wound that is at least 1 centimeter wide, created by surgical removal of skin and healing on its own, can join if they can give informed consent. Exclusions include current smoking, poorly controlled diabetes or kidney issues, serious vein or artery problems in the leg, prior radiation to the area, and several other medical or safety concerns. The trial is being run at Northwestern University in Chicago, plans to enroll about 80 people, and the study will monitor wounds over a 6-month period with assessors who don’t know which treatment group participants are in.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:Patients will be identified through the clinic where their skin is to be treated by excisional surgery on the lower leg. Those considered for enrollment must also meet the following criteria:
• • 1. \>18 years of age
• • 2. Wound size of at least 1 cm in width
• • 3. Cutaneous excision of the lower leg
• • 4. Surgeon elected repair of healing by secondary intention
• • 5. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
• Exclusion Criteria:
• • 1. Current smoker
• • 2. Uncontrolled diabetes mellitus
• • 3. Uncontrolled hypothyroidism
• • 4. Severe renal impairment or hypoalbuminemia
• • 5. Chronic lymphedema
• • 6. Severe venous insufficiency (large varicose veins, atrophie blanche)
• • 7. Arterial insufficiency (ABI \< 0.8)
• • 8. Rubber or rubber accelerator allergy
• • 9. Prior radiation to the surgical site
• • 10. History or evidence of a clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study
• • 11. Subject un willing to sign an IRB approved consent form
• • 12. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible