Compression and CO2 Laser for Leg Wounds

Not Applicable

• Conditions: Wound Healing
• Interventions: Other: Compression bandages; Other: Standard wound dressings; Device: Fractional ablative carbon dioxide laser

• Registration Number: NCT04198454
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-02-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Compression bandages	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.
Compression bandages with FACL	Compression bandages	Class I compression (20-30 mmHg) bandage or stocking with FACL.
Standard wound dressings	Standard wound dressings	Wound dressings alone consisting of gauze and skin tape to cover the wound.
Compression bandages with FACL	Fractional ablative carbon dioxide laser	Class I compression (20-30 mmHg) bandage or stocking with FACL.

Primary Outcome Measures

Name	Time	Method
Mean change wound size as determined by measurements	Baseline to 6 months

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States