Clinical trial NCT03417661: An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
Official title: An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antimicrobial Effect
Lead sponsor: Gama Healthcare Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of bacterial load at each test site.
timeFrame: 1 and 10 minutes after application.
Secondary outcomes:
measure: Persistence of reduction in bacterial load at each test site.
timeFrame: 30 minutes - 24 hours
measure: Relative efficacy compared to a positive control
timeFrame: 1-10 minutes, and 30 minutes - 24 hours
measure: 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.
timeFrame: From application
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Surrey Clinical Research Centre
state: Surrey
Study officials:
affiliation: Medical Director
name: Daryl Bendel
role: PRINCIPAL_INVESTIGATOR
References: