Compression and CO2 Laser for Leg Wounds

Northwestern University

Status: Invitation-only

Conditions: Wound Healing

Treatments: Device: Fractional ablative carbon dioxide laser; Other: Standard wound dressings; Other: Compression bandages

Study type: Interventional

Funder types: Other

Identifiers

NCT04198454

STU00211239

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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80 participants in 3 patient groups

Compression bandages

Active Comparator group

Description:

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.

Treatment:

Other: Compression bandages

Standard wound dressings

Other group

Description:

Wound dressings alone consisting of gauze and skin tape to cover the wound.

Treatment:

Other: Standard wound dressings

Compression bandages with FACL

Experimental group

Description:

Class I compression (20-30 mmHg) bandage or stocking with FACL.

Treatment:

Other: Compression bandages

Device: Fractional ablative carbon dioxide laser