The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.

Study Overview

• Status: Terminated
• Conditions: Herpes Simplex Keratitis
• Intervention / Treatment: Procedure: Corneal sampling

Detailed Description

In our center, the flocked swabs became an important tool in the corneal sampling for viral keratitis, replacing rightly or wrongly the former traditional fibers swab. No research was specifically designed to study the corneal taking with these swabs. Nevertheless, numerous reasons would motivate it, because of the peculiarities in ophthalmology: the corneal sampling has to be made with the slit lamp rather than in a macroscopic manner; the corneal lesion are often millimetre-length and confined; the histology of the cornea is unique and compares only imperfectly with other structures of the human body like the nasal mucosa. In these circumstances, the properties of the stalk (rigidity, length) and of its extremity (roughness, textures, absorbance) can influence the quality of the sampling and the final result of the culture.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S 4L8
      • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)

Exclusion Criteria:

• Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flocked swab (Copan 519CS01); Sampling of the cornea by the flocked swab	Procedure: Corneal sampling; Slit lamp corneal sampling with a Swab
Experimental: Traditionnal fiber swab (Copan 164KS01); Sampling of the cornea by the traditional finer swab	Procedure: Corneal sampling; Slit lamp corneal sampling with a Swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result of the culture	The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.	1 month after the initial visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time before positivity of the culture	If the culture is positive for Herpes simplex virus, what is the time lapse(in day) before the culture became positive. The research team will collect the data 1 month in average after the initial visit by examining the microbiologic data of the laboratory.	1 month after the initial visit
Viral load concentration	Quantitative polymerase chain reaction (PCR) will be on a part of the sampling 1 month after the initial visit. The result will be the concentration of virus in number/ml detected in the sampling	1 month after the initial visit

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Patricia-Ann Laughrea, MD, CRMC(C), Centre de recherche du CHU de Québec; Université Laval

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Flocked swab; Traditional fiber swab; Herpes simplex epithelial keratitis; Quantitative PCR
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Eye Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Corneal Diseases; Herpesviridae Infections; Eye Infections; Eye Infections, Viral; Keratitis; Herpes Simplex; Keratitis, Herpetic
• Other Study ID Numbers: DR-002-1399, 2012-1649