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

G

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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