Back to resultsCompression and CO2 Laser for Leg Wounds
Primary Purpose
Wound Healing
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression bandages
Standard wound dressings
Fractional ablative carbon dioxide laser
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
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:
- >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
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
Experimental
Arm Label
Compression bandages
Standard wound dressings
Compression bandages with FACL
Arm 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.
Wound dressings alone consisting of gauze and skin tape to cover the wound.
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Outcomes
Primary Outcome Measures
Mean change wound size as determined by measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT04198454
First Posted
December 12, 2019
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04198454
Brief Title
Compression and CO2 Laser for Leg Wounds
Official Title
Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential, multiple assignment, randomized trials (SMARTs)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression bandages
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard wound dressings
Arm Type
Other
Arm Description
Wound dressings alone consisting of gauze and skin tape to cover the wound.
Arm Title
Compression bandages with FACL
Arm Type
Experimental
Arm Description
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Intervention Type
Other
Intervention Name(s)
Compression bandages
Intervention Description
Class I (20-30 mmHg) compression bandages or stocking
Intervention Type
Other
Intervention Name(s)
Standard wound dressings
Intervention Description
Wound dressings alone consisting of gauze and skin tape to cover the wound
Intervention Type
Device
Intervention Name(s)
Fractional ablative carbon dioxide laser
Intervention Description
Participant will have laser applied to their wound bed.
Primary Outcome Measure Information:
Title
Mean change wound size as determined by measurements
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
>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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Compression and CO2 Laser for Leg Wounds
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