Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
研究概览
简要总结
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars.
This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •At least 1 second or third degree burn wound that required treatment with split-thickness skin grafts
- •Donor site with at least a 4 x 4 inch surface area
- •Able to return to clinical site for treatments and assessments of burn injuries
排除标准
- •Pregnancy or nursing
- •Oral retinoid medication use within the past 6 months
- •Medical history of Ehlers-Danlos syndrome, AIDS
- •Nutritional deficiencies in the opinion of the investigator that would affect wound healing
- •Wounds complicated by clinically significant infection within past 30 days
结局指标
主要结局
Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
时间窗: 2 months
The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment. The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.
次要结局
未报告次要终点