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

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ClinicalTrials.gov Identifier: NCT02045082
Recruitment Status : Terminated
First Posted : January 24, 2014
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

January 21, 2014
January 24, 2014
February 26, 2016
October 2013
October 2015   (Final data collection date for primary outcome measure)
Result of the culture [ Time Frame: 1 month after the initial visit ]
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.
Same as current
Complete list of historical versions of study NCT02045082 on ClinicalTrials.gov Archive Site
  • Time before positivity of the culture [ Time Frame: 1 month after the initial visit ]
    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.
  • Viral load concentration [ Time Frame: 1 month after the initial visit ]
    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
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Herpes Simplex Keratitis
Procedure: Corneal sampling
Slit lamp corneal sampling with a Swab
  • Experimental: Flocked swab (Copan 519CS01)
    Sampling of the cornea by the flocked swab
    Intervention: Procedure: Corneal sampling
  • Experimental: Traditionnal fiber swab (Copan 164KS01)
    Sampling of the cornea by the traditional finer swab
    Intervention: Procedure: Corneal sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
146
250
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT02045082
DR-002-1399, 2012-1649
Yes
Not Provided
Not Provided
CHU de Quebec-Universite Laval
CHU de Quebec-Universite Laval
Not Provided
Principal Investigator: Patricia-Ann Laughrea, MD, CRMC(C) Centre de recherche du CHU de Québec; Université Laval
CHU de Quebec-Universite Laval
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP