Antimicrobial Effect Clinical Trial
Official title:
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
Verified date | July 2020 |
Source | Gama Healthcare Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
Status | Completed |
Enrollment | 93 |
Est. completion date | September 18, 2019 |
Est. primary completion date | June 6, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Surrey Clinical Research Centre | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
Gama Healthcare Ltd. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | 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 | |
Secondary | Relative efficacy compared to a positive control | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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