This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
HEXI-PREP by Clinell is a sterile single sachet wipe containing chlorhexidine gluconate and isopropyl alcohol. Both active ingredients are well-established ingredients commonly used for their disinfectant properties. This trial is designed to assess the superiority of HEXI-PREP by Clinell Wipe against a negative control, and also to demonstrate the relative efficacy of HEXI-PREP by Clinell WIpe against a similar commercially available product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
93
Sterile single sachet wipe containing 3ml solution.
Sterile applicator containing 3ml solution.
Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom
Reduction of bacterial load at each test site.
Reduction in bacterial load of the test product in comparison to a negative control.
Time frame: 1 and 10 minutes after application.
Persistence of reduction in bacterial load at each test site.
Reduction in bacterial load of the test product in comparison to a negative control over a longer duration.
Time frame: 30 minutes - 24 hours
Relative efficacy compared to a positive control
To assess the reduction in bacterial load after application when compared to a similar commercially available product.
Time frame: 1-10 minutes, and 30 minutes - 24 hours
Number of participants with treatment-related adverse events as assessed by a 5-point scale based on comment from the participant, and recorded assessments of erythema and oedema.
Assessed by comments from the participant logged on a five-point scale, and recorded assessments of erythema and oedema by the investigator. Erythema and oedema are each assessed on a five-point scale of none to severe.
Time frame: From application
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