A randomised single-blind comparison of the effectiveness of the high-level disinfectants Tristel Fusion (chlorine dioxide) and Cidex OPA (ortho-phthaldehyde) for use with flexible cystoscopes

A randomised single-blind comparison of the rate of urinary tract infections in participants undergoing flexible cystoscopy when the flexible cystoscope is disinfected with Tristel Fusion (chlorine dioxide) compared with Cidex OPA (ortho- phthaldehyde)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000687291

Enrollment

180

Registered

2009-08-11

Start date

2009-09-17

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are several methods and agents which can be used to provide high-level disinfection of ‘semi-critical’ instruments such as flexible cystoscopes, however non-corrosive methods are required because of the composition of the instrument. Cidex OPA (ortho-Phthalaldehyde; 1,2 – benzenedicarboxaldehyde) has been widely used for high level disinfection but may elicit an allergic reaction in workers if protective equipment is not used and the vapours produced may be an irritant to the respiratory tract and eyes (Cidex OPA Directions for Use; 2004). Tristel Solutions Limited (UK) produces a range of high level disinfectant products which use chlorine dioxide chemistry and the products have also been used as a disinfectant for a wide variety of instruments and surfaces without safety issues (Tristel data on file). Therefore the use of Tristel is expected to pose a very low risk to patients, surgeons and nurses. If Tristel Fusion is shown to be at least as effective as Cidex OPA in terms of post-intervention complications (infection/inflammation) for patients, less in-use problems for the surgeons and nurses, then it may be a preferable product to use for high-level disinfection of flexible cystoscopes.

Interventions

Tristel Fusion consists of 100 ml chlorine dioxide in aqueous solution. This is diluted in five litres of water. The flexible cystoscope is then immersed in this solution for five minutes and then rinsed thoroughly.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Participants requiring a flexible cystoscope and who provide written informed consent will be eligible to participate. Other inclusion criteria are a negative MSU at baseline, no symptoms of urinary tract infection (UTI) on the day of investigation, no specific indication for parenteral antibiotic prophylaxis (e.g. artificial heart valve), no current indwelling urinary catheter and no recent surgery on the urogenital tract.

Exclusion criteria

Exclusion criteria include the requirement of a biopsy during the procedure.

Outcome results