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

NCT ID: NCT03417661

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2019-09-18

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.

Conditions

Antimicrobial Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

HEXI-PREP By Clinell Wipes

Intervention Type: DRUG

Sterile single sachet wipe containing 3ml solution.

Placebos

Intervention Type: DRUG

Sterile saline (0.9% w/v) wipe, containing 3ml of solution.

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.

Group Type: EXPERIMENTAL

HEXI-PREP By Clinell Wipes

Intervention Type: DRUG

Sterile single sachet wipe containing 3ml solution.

Chloraprep

Intervention Type: DRUG

Sterile applicator containing 3ml solution.

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.

Group Type: EXPERIMENTAL

Chloraprep

Intervention Type: DRUG

Sterile applicator containing 3ml solution.

Placebos

Intervention Type: DRUG

Sterile saline (0.9% w/v) wipe, containing 3ml of solution.

Interventions

HEXI-PREP By Clinell Wipes

Sterile single sachet wipe containing 3ml solution.

Intervention Type: DRUG

Chloraprep

Sterile applicator containing 3ml solution.

Intervention Type: DRUG

Placebos

Sterile saline (0.9% w/v) wipe, containing 3ml of solution.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gama Healthcare Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daryl Bendel

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

Surrey Clinical Research Centre

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

GH001

Identifier Type: -

Identifier Source: org_study_id