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临床试验/NCT01926392
NCT01926392已完成4 期

A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds

University of Virginia1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Pain level

研究概览

简要总结

Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult inpatients with partial thickness burns

排除标准

  • superficial or full thickness burns, facial burns, intubated or sedated, pediatric

研究组 & 干预措施

water-soluble therapy

Experimental

The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis

干预措施: water-soluble therapy (Drug)

water-soluble therapy

Experimental

The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis

干预措施: silver sulfadiazine (Drug)

silver sulfadiazine

Active Comparator

The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis

干预措施: water-soluble therapy (Drug)

silver sulfadiazine

Active Comparator

The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis

干预措施: silver sulfadiazine (Drug)

结局指标

主要结局

Pain level

时间窗: 180 minutes

Pain is assessed on a 0-10 point scale using both the patient's reported value and correlating with the value derived from nursing assessment using the visual analog scale. This is recorded at defined time points before, during, and after the dressing change

次要结局

  • time to perform dressing changes(up to 180 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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