Antimicrobial Effect
Conditions
Brief summary
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
Detailed description
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.
Interventions
DRUGHEXI-PREP By Clinell Wipes
Sterile single sachet wipe containing 3ml solution.
DRUGChloraprep
Sterile applicator containing 3ml solution.
DRUGPlacebos
Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
Sponsors
Gama Healthcare Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants 18 - 70 years, who have provided written informed consent to participate in the study * Test sites with a bacterial baseline count of ≥ 5.0 log10/cm2 at the inguinal (groin) test administration sites. ≥4.0 log10/cm2 at the abdominal test site and \>3.0 log10/cm2 at the clavicular and/or median cubital regions at Day - 5 of screening * Participants, who in the opinion of the Investigator, are in suitable health for inclusion in the study.
Exclusion criteria
* Exposure of the test sites to strong detergents, solvents or other irritants during the 14- day pre-test conditioning period or during the test period. * Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period. * Any known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine. * Active skin rashes or breaks in the skin at the test site. * Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site. * Showering or bathing after the Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1). * Participation in another clinical trial within 90 days preceding randomisation. * Pregnant or breastfeeding women. * Any other medical condition, which in the opinion of the Investigator, should preclude participation. * Unwillingness to fulfil the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of bacterial load at each test site. | 1 and 10 minutes after application. | Reduction in bacterial load of the test product in comparison to a negative control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of reduction in bacterial load at each test site. | 30 minutes - 24 hours | Reduction in bacterial load of the test product in comparison to a negative control over a longer duration. |
| Relative efficacy compared to a positive control | 1-10 minutes, and 30 minutes - 24 hours | To assess the reduction in bacterial load after application when compared to a similar commercially available product. |
| 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. | From application | 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. |
Countries
United Kingdom
Outcome results
None listed