Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean change wound size as determined by measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Compression bandages (Other)
Standard wound dressings
Wound dressings alone consisting of gauze and skin tape to cover the wound.
干预措施: Standard wound dressings (Other)
Compression bandages with FACL
Class I compression (20-30 mmHg) bandage or stocking with FACL.
干预措施: Fractional ablative carbon dioxide laser (Device)
Compression bandages with FACL
Class I compression (20-30 mmHg) bandage or stocking with FACL.
干预措施: Compression bandages (Other)
结局指标
主要结局
Mean change wound size as determined by measurements
时间窗: Baseline to 6 months
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University