A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.
详细描述
A smear from the lesional skin of the patients suspected having Herpes simplex, Herpes zoster and Varicella zoster skin infections will be collected (in a clinical routine setting). The specimen will be stained with methylene blue in addition to the Giemsa stain. Polymerase chain reaction study for herpes antigen will be performed in some of the specimens. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated from the results of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with clinically suspected of having herpes simplex, herpes zoster, varicella zoster skin infections.
- •Those who have vesicular skin lesion such as acute eczema, Paederus dermatitis.
- •Those are well cooperative.
- •Age > 18 years old.
排除标准
- •Those who are not willing to have specimen from skin lesions to be collected.
研究组 & 干预措施
Negative control
Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
干预措施: Giemsa stain (Diagnostic Test)
Case
Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
干预措施: Giemsa stain (Diagnostic Test)
Negative control
Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
干预措施: Methylene blue (Diagnostic Test)
Case
Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
干预措施: Methylene blue (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: 24 weeks
Positive results from staining compared with number of cases
次要结局
- Factors that contribute the results from Methylene blue staining(24 weeks)
- Specificity(24 weeks)
研究者
Pawinee Rerknimitr
Assistant professor
Chulalongkorn University