Tzanck Smear With Methylene Blue Stain for Herpes

Study Overview
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Brief Summary
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To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.

Detailed Description
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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.

Official Title
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A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections

Conditions
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Herpes Simplex, Herpes Zoster, Varicella Zoster

Intervention / Treatment
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* Diagnostic Test: Methylene blue
* Diagnostic Test: Giemsa stain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Those who are not willing to have specimen from skin lesions to be collected.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case<br>Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection. | Diagnostic Test: Methylene blue<br>* working solution methylene blue<br>Diagnostic Test: Giemsa stain<br>* working solution Giemsa stain (Wolbach's modification)<br>|
| Sham Comparator: Negative control<br>Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis | Diagnostic Test: Methylene blue<br>* working solution methylene blue<br>Diagnostic Test: Giemsa stain<br>* working solution Giemsa stain (Wolbach's modification)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Positive results from staining compared with number of cases | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors that contribute the results from Methylene blue staining | Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion. | 24 weeks | 
| Specificity |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methylene blue, Giemsa, Tzanck smear