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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Québec, CHU de Québec

Dates:
Date Received: January 21, 2014
Date Started: October 2013
Date Completion:
Last Updated: February 25, 2016
Last Verified: January 2016