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临床试验/NCT00139100
NCT00139100已完成不适用

Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年2月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Reported or observed severity of these acute attacks.

研究概览

简要总结

Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being.

Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene).

排除标准

  • Don't meet inclusion criteria.

结局指标

主要结局

Reported or observed severity of these acute attacks.

Incidence of bacterial "acute attacks", assessed monthly.

Duration of acute attacks.

次要结局

  • Demonstrated knowledge and ability to wash leg appropriately during home visits.
  • Number of bars of soap used per patient per month.
  • Reported patient satisfaction with soap.
  • Process measures
  • Reported frequency of leg washing.

研究者

研究点 (2)

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