Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in scar assessment evaluation
研究概览
简要总结
Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
详细描述
Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars
The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant is blinded
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 to 21
- •Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
- •Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
- •Entry into this study is open to pediatric patients of both genders.
- •Entry into this study is open to pediatric patients of all ethnic backgrounds.
- •Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test
排除标准
- •Patients with scars less than 2 years old
- •Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
- •Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.
结局指标
主要结局
Change in scar assessment evaluation
时间窗: Prior to initial treatment and no sooner than 3 months following last treatment
Patient and Observer Scar Assessment Scale
次要结局
未报告次要终点