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临床试验/NCT04921540
NCT04921540Unknown不适用

Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné

University Hospital, Caen4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
4
主要终点
Relapses

研究概览

简要总结

Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad.

For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market.

The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study.

It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.

研究设计

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

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ingrown toenail
  • Patient informed and with signed informed consent

排除标准

  • Medical history of ingrown toenail on the concerned nail
  • Other nail disease
  • Pregnancy
  • Allergy to local anesthetic or to trichloroacetic acid

结局指标

主要结局

Relapses

时间窗: one year

Relapses of ingrown toenail on the operated nail

次要结局

  • Complications(At one week and one month after surgery)
  • Pain on the nail(Baseline, one week and one month after surgery)
  • Time before restart sport(Restart sport at one month yes/no)
  • Gain of quality of life(Baseline and one month after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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