Compression and CO2 Laser for Leg Wounds

• Sponsor: Northwestern University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04198454
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 45.4
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Healing	Other: Compression bandages; Other: Standard wound dressings; Device: Fractional ablative carbon dioxide laser	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Sequential, multiple assignment, randomized trials (SMARTs)Sequential, multiple assignment, randomized trials (SMARTs)
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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+)
• Actual Study Start Date: Feb 17, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean change wound size as determined by measurements [Baseline to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT04198454
• Other Study ID Numbers: STU00211239
• First Posted: Dec 13, 2019
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Dec 2, 2021