Status:
COMPLETED
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
Lead Sponsor:
Gama Healthcare Ltd.
Conditions:
Antimicrobial Effect
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 disinfec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03417661
Start Date
June 29 2018
End Date
September 18 2019
Last Update
July 22 2020
Active Locations (1)
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1
Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom