Compression and CO2 Laser for Leg Wounds

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)

Conditions
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Wound Healing

Intervention / Treatment
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* Other: Compression bandages
* Other: Standard wound dressings
* Device: Fractional ablative carbon dioxide laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential, multiple assignment, randomized trials (SMARTs)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression bandages<br>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. | Other: Compression bandages<br>* Class I (20-30 mmHg) compression bandages or stocking<br>|
| Other: Standard wound dressings<br>Wound dressings alone consisting of gauze and skin tape to cover the wound. | Other: Standard wound dressings<br>* Wound dressings alone consisting of gauze and skin tape to cover the wound<br>|
| Experimental: Compression bandages with FACL<br>Class I compression (20-30 mmHg) bandage or stocking with FACL. | Other: Compression bandages<br>* Class I (20-30 mmHg) compression bandages or stocking<br>Device: Fractional ablative carbon dioxide laser<br>* Participant will have laser applied to their wound bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change wound size as determined by measurements |  | Baseline to 6 months |