An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes

An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation

This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.

Study Overview

• Status: Completed
• Conditions: Antimicrobial Effect
• Intervention / Treatment: Drug: HEXI-PREP By Clinell Wipes; Drug: Placebos; Drug: Chloraprep

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom
      • Surrey Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEXI-PREP By Clinell Wipes vs Placebo; 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.	Drug: HEXI-PREP By Clinell Wipes; Sterile single sachet wipe containing 3ml solution.; Drug: Placebos; Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
Experimental: HEXI-PREP By Clinell Wipes vs Chloraprep; 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.	Drug: HEXI-PREP By Clinell Wipes; Sterile single sachet wipe containing 3ml solution.; Drug: Chloraprep; Sterile applicator containing 3ml solution.
Experimental: Chloraprep vs Placebo; 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.	Drug: Placebos; Sterile saline (0.9% w/v) wipe, containing 3ml of solution.; Drug: Chloraprep; Sterile applicator containing 3ml solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Gama Healthcare Ltd.
• Investigators: Principal Investigator: Daryl Bendel, Medical director

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GH001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No