Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02659072 |
| Other study ID # |
NI14013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
November 2016 |
Study information
| Verified date |
March 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans
vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination
and probe disinfection. This will allow modeling the risk of HPV transmission, and could
contribute establishing future guidelines for reducing the risk of transmission of
microorganisms and the risk of infection through TVS.
Description:
Prevention of infection Endo Vaginal sonography. Brief Summary
Background Trans vaginal sonography (TVS) is widely used in obstetrics and gynecology.
Because of the relative lack of data, there is no universal agreement on how to prevent the
transmission of pathogens and the risk of infection through TVS. Whereas American guideline
are more stringent, French health authorities recommend low-level disinfection of the probe
between two patients with the use of probe cover, and intermediate level disinfection at
least once daily and in case of visible contamination of the probe, or rupture of the probe
cover. For the coupling gel, guidelines do not agree on whether or not it should be sterile.
Transmitting infectious agents may result from a variety of causes: failure to disinfect the
probe, contaminated gel, contamination of the probe cover due to incorrect manipulation and
failure to comply with hand washing or disinfection.
Due to resistance to disinfection, high prevalence, and potential oncogenic role, we will use
HPV as a marker for the presence of pathogens on the probe, the probe cover, and the
environment.
Objectives Primary objective: to assess the presence of HPV on bare probes and on probes with
their probe-cover in routine practice
Secondary objectives:
1. - To assess compliance to guidelines of prevention of pathogens
2. - To identify factors associated with the presence of HPV on the probe
2a Factors related to the procedure Compliance to disinfection guidelines prior to performing
TVS Rank of procedure since last daily midlevel disinfection Presence of HPV on the
ultrasound machine key board, a proxy of the environment 2b Factors related to the center in
which TVS is performed Compliance to daily disinfection guidelines Traceability of the
disinfection processes Type of center (emergency clinic /planned sessions / obstetrics /
gynecology /IVF monitoring) 3 - To estimate the incidence of probe cover rupture and of
visible probe contamination by bodily fluids 4 - To model the cost effectiveness of
strategies of disinfection
Methods Type of study: observational survey
Main outcome criterion:
Percentage and 95 % confidence interval of TVS procedure
- with bare probe positive for HPV
- with covered probe positive for HPV Statistical unit: each procedure surveyed Viral
assays HPV DNA detection will be performed on all samples (keyboard, bare and covered
probe) using the cobas® HPV Test Kit (Roche): This test allows to detect the presence of
cellular DNA and DNA of 14 high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52,
56, 58, 59, 66 and 68) and to specifically identify the presence of HPV16 and 18. In
case of positive result for both bare and covered probe, a detection of HPV complete
episomal genome will be performed, and circular HPV DNA will be amplified using a
polymerase whch selectively amplifies circular double-stranded DNA with specific
degenerate HPV primers. The amplicons will then be sequenced using specific HPV primers
GP5 + / GP6 + (MARINCEVIC Y-Zuniga et al, 2012, Virology).
Secondary outcome criteria Percentage of procedures with keyboard positive for HPV Percentage
of procedures with visible rupture of probe cover Percentage of procedures with visibly
tainted probes Percentage of procedures with visible rupture of probe cover during previous
procedure Percentage of procedures with visibly tainted probes during previous procedure
Percentage of presence of each disinfection guideline item since last procedure and before
the probe is tested for the presence of HPV Percentage of centers with a written protocol
complying with disinfection guidelines Percentage of centers with traceability of
disinfection procedures.
Number of observations: 1000 TVS procedures
Inclusion criterion: Any TVS performed in a participating center during an observation
session Exclusion criteria: TVS with invasive procedure. Patient refusal Center selection:
private and public centers from the Ile de France region, performing TVS routinely, who
volunteered to enroll.
Perspectives Evaluating the presence of HPV on TVS probes in relation with the actual
behavior of professionals in routine practice will help us modeling the risk of transmitting
pathogens during TVS and may contribute to establishing prevention guidelines
