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

NCT03417661 | Completed Phase 3

• 1 other identifier: GH001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antimicrobial Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Persistence of reduction in bacterial load at each test site.

  30 minutes - 24 hours

• Relative efficacy compared to a positive control

  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.

  From application

Study Arms (3)

HEXI-PREP By Clinell Wipes vs Placebo

EXPERIMENTAL

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; Drug: Placebos

HEXI-PREP By Clinell Wipes vs Chloraprep

EXPERIMENTAL

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; Drug: Chloraprep

Chloraprep vs Placebo

EXPERIMENTAL

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: Chloraprep; Drug: Placebos

Interventions

HEXI-PREP By Clinell Wipes DRUG

Sterile single sachet wipe containing 3ml solution.

HEXI-PREP By Clinell Wipes vs Chloraprep; HEXI-PREP By Clinell Wipes vs Placebo

Chloraprep DRUG

Sterile applicator containing 3ml solution.

Chloraprep vs Placebo; HEXI-PREP By Clinell Wipes vs Chloraprep

Placebos DRUG

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

Chloraprep vs Placebo; HEXI-PREP By Clinell Wipes vs Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gama Healthcare Ltd.: lead

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, United Kingdom

Location

Study Officials

• Daryl Bendel

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 31, 2018
• Study Start: June 29, 2018
• Primary Completion: June 6, 2019
• Study Completion: September 18, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

GB (1)