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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEXI-PREP By Clinell Wipes vs Placebo | Experimental | Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points. |
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| HEXI-PREP By Clinell Wipes vs Chloraprep | Experimental | Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points. |
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| Chloraprep vs Placebo | Experimental | Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEXI-PREP By Clinell Wipes | Drug | Sterile single sachet wipe containing 3ml solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of bacterial load at each test site. | Reduction in bacterial load of the test product in comparison to a negative control. | 1 and 10 minutes after application. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes - 24 hours |
| Relative efficacy compared to a positive control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl Bendel | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey Clinical Research Centre | Guildford | Surrey | United Kingdom |
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| Chloraprep | Drug | Sterile applicator containing 3ml solution. |
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| Placebos | Drug | Sterile saline (0.9% w/v) wipe, containing 3ml of solution. |
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To assess the reduction in bacterial load after application when compared to a similar commercially available product.
| 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. | From application |