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

Gama Healthcare

Status and phase: Completed; Phase 3

Conditions: Antimicrobial Effect

Treatments: Drug: Chloraprep; Drug: HEXI-PREP By Clinell Wipes; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT03417661

GH001

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups

HEXI-PREP By Clinell Wipes vs Placebo

Experimental group

Description:

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.

Treatment:

Drug: HEXI-PREP By Clinell Wipes

Drug: Placebos

HEXI-PREP By Clinell Wipes vs Chloraprep

Experimental group

Description:

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.

Treatment:

Drug: HEXI-PREP By Clinell Wipes

Drug: Chloraprep

Chloraprep vs Placebo

Experimental group

Description:

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.

Treatment:

Drug: Chloraprep

Drug: Placebos