Randomized, Investigator-blinded Study of Compression in Wound Healing with and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Wound Healing
- 发起方
- Northwestern University
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean change wound size as determined by measurements
- 状态
- Enrolling By Invitation
- 最后更新
- 去年
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.
研究者
Murad Alam
Professor of Dermatology
Northwestern University
入排标准
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
结局指标
主要结局
Mean change wound size as determined by measurements
时间窗: Baseline to 6 months