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临床试验/NCT06362226
NCT06362226撤回1 期

Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management

Virginia Commonwealth University0 个研究点目标入组 10 人开始时间: 2026年6月5日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Steroid/Antibiotic (Maxitrol) (Drug)

Group A: 5-FU/Kenalog

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

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