Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Northwestern University
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Mean change wound size as determined by measurements
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg.
This is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •>18 years of age
- •Wound size of at least 1 cm in width
- •Cutaneous excision of the lower leg
- •Surgeon elected repair of healing by secondary intention
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria
- •Current smoker
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypothyroidism
- •Severe renal impairment or hypoalbuminemia
- •Chronic lymphedema
- •Severe venous insufficiency (large varicose veins, atrophie blanche)
- •Arterial insufficiency (ABI < 0.8)
- •Rubber or rubber accelerator allergy
- •Prior radiation to the surgical site
- •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
- •Subject un willing to sign an IRB approved consent form
- •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
Arms & Interventions
Compression bandages
Class I (20-30 mmHg) compression bandages or stocking. This is considered a standard measure in the recovery of lower extremity wounds and often recommended.
Intervention: Compression bandages (Other)
Standard wound dressings
Wound dressings alone consisting of gauze and skin tape to cover the wound.
Intervention: Standard wound dressings (Other)
Compression bandages with FACL
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Intervention: Fractional ablative carbon dioxide laser (Device)
Compression bandages with FACL
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Intervention: Compression bandages (Other)
Outcomes
Primary Outcomes
Mean change wound size as determined by measurements
Time Frame: Baseline to 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Professor of Dermatology
Northwestern University