Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Comparison of infection rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog & topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.
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
- 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
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •Mechanism of Injury including explosion, thermal, electrical
- •Clinical diagnosis of periorbital burn wound
- •Second degree or less periorbital or lid bur
- •No previous surgical treatment for wound management
- •Partial Deep thickness Periorbital burn
- •Partial Thickness Burn
- •Superficial Burn
- •Periocular lesions with globe involvement
排除标准
- •Recent surgical intervention for wound
- •Full Thickness and or "Third degree Burns"
- •Imprisoned Inmates
- •Chemical Burn
- •Pregnant women
- •Individuals whom are not adults >18 years of age
研究组 & 干预措施
Group B: Steroid/Antibiotic
干预措施: Steroid/Antibiotic (Maxitrol) (Drug)
Group A: 5-FU/Kenalog
干预措施: 5-FU/Kenalog (Drug)
结局指标
主要结局
Comparison of infection rate
时间窗: 12 months
This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other.
Comparison of wound healing time
时间窗: 12 months
This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery.
Comparison of complication rates
时间窗: 12 months
Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment.
次要结局
- Comparison of cosmetic outcome through the Vancouver scar scale (VSS)(12 months)
- Comparison of quality of life(12 months)
- Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)(12 months)
- Comparison of pain level(12 months)