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临床试验/NCT01341041
NCT01341041已完成早期 1 期

Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
201
试验地点
2
主要终点
cosmesis

研究概览

简要总结

This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.

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)

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

  • 18-100 years old
  • simple laceration requiring irrigation & sutures
  • patient has method of contact
  • patient is willing to return to ED in 3-4 mths

排除标准

  • immunocompromised
  • consult required for repair
  • require antibiotics

结局指标

主要结局

cosmesis

时间窗: 72 hrs post-ED visit

Cosmesis will be assessed by taking pictures of the wound at presentation, upon receiving sutures, 48-72 hrs later, and 3-4 mths later. At 3-4 mths the patient will rate how well they think the wound healed, via a visual analog scale. At that time, two blinded ER physicians will do this as well. They will also designate a wound evaulation score, based on criteria that will be provided to them. Two blinded plastic surgeons will assess all photographs, visual analog scores. and wound evaluation scores, and provide their own visual analog scale assessment of how well each wound healed.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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