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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417661
Recruitment Status : Unknown
Verified July 2018 by Gama Healthcare Ltd..
Recruitment status was:  Recruiting
First Posted : January 31, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Gama Healthcare Ltd.

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

Condition or disease Intervention/treatment Phase
Antimicrobial Effect Drug: HEXI-PREP By Clinell Wipes Drug: Chloraprep Drug: Placebos Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


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: Chloraprep
Sterile applicator containing 3ml solution.

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




Primary Outcome Measures :
  1. Reduction of bacterial load at each test site. [ Time Frame: 1 and 10 minutes after application. ]
    Reduction in bacterial load of the test product in comparison to a negative control.


Secondary Outcome Measures :
  1. Persistence of reduction in bacterial load at each test site. [ Time Frame: 30 minutes - 24 hours ]
    Reduction in bacterial load of the test product in comparison to a negative control over a longer duration.

  2. Relative efficacy compared to a positive control [ Time Frame: 1-10 minutes, and 30 minutes - 24 hours ]
    To assess the reduction in bacterial load after application when compared to a similar commercially available product.

  3. 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. [ Time Frame: From application ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417661


Contacts
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Contact: Jo Leahy 01483689788 j.leahy@surrey.ac.uk
Contact: Victoria Revell 01483689383 v.revell@surrey.ac.uk

Locations
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United Kingdom
Surrey Clinical Research Centre Recruiting
Guildford, Surrey, United Kingdom
Contact: Jo Leahy    01483689788    j.leahy@surrey.ac.uk   
Contact: Victoria Revell    01483689383    v.revell@surrey.ac.uk   
Sponsors and Collaborators
Gama Healthcare Ltd.
Investigators
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Principal Investigator: Daryl Bendel Medical Director
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Responsible Party: Gama Healthcare Ltd.
ClinicalTrials.gov Identifier: NCT03417661    
Other Study ID Numbers: GH001
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents