Antimicrobial EffectPhase 3NCT03417661
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
A Phase 3 study testing HEXI-PREP By Clinell Wipes and Chloraprep in people with Antimicrobial Effect, run by Gama Healthcare Ltd. at 1 site in United Kingdom.
Trial summary
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Effect
- What is being tested?
- HEXI-PREP By Clinell Wipes and Chloraprep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2018to 18 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
Read the 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
- Being tested
- HEXI-PREP By Clinell Wipes, Chloraprep, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEXI-PREP By Clinell WipesDrug
Sterile single sachet wipe containing 3ml solution.
ChloraprepDrug
Sterile applicator containing 3ml solution.
PlacebosDrug
Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Chloraprep; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bacterial load at each test site.
Reduction in bacterial load of the test product in comparison to a negative control.
Measured: 1 and 10 minutes after application.
Secondary outcomes (3)
Persistence of reduction in bacterial load at each test site.
Reduction in bacterial load of the test product in comparison to a negative control over a longer duration.
Measured: 30 minutes - 24 hours
Relative efficacy compared to a positive control
To assess the reduction in bacterial load after application when compared to a similar commercially available product.
Measured: 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.
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.
Measured: From application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start29 Jun 2018
- Primary completion6 Jun 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gama Healthcare Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daryl Bendel, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417661
- Sponsor's protocol ID
- GH001
- Status last verified
- Jul 2020
- First submitted
- 9 Jan 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
- ClinicalTrials.gov ID
- NCT03417661
- Acronym / sponsor ID
- GH001
- Conditions
- Antimicrobial Effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gama Healthcare Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEXI-PREP By Clinell Wipes vs Placebo | Experimental | Drug: HEXI-PREP By Clinell Wipes, Drug: PlacebosBoth 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. |
| HEXI-PREP By Clinell Wipes vs Chloraprep | Experimental | Drug: HEXI-PREP By Clinell Wipes, Drug: ChloraprepBoth 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. |
| Chloraprep vs Placebo | Experimental | Drug: Chloraprep, Drug: PlacebosBoth 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEXI-PREP By Clinell WipesSterile single sachet wipe containing 3ml solution. | Drug | HEXI-PREP By Clinell Wipes vs Chloraprep, HEXI-PREP By Clinell Wipes vs Placebo |
| ChloraprepSterile applicator containing 3ml solution. | Drug | Chloraprep vs Placebo, HEXI-PREP By Clinell Wipes vs Chloraprep |
| PlacebosSterile saline (0.9% w/v) wipe, containing 3ml of solution. | Drug | Chloraprep vs Placebo, HEXI-PREP By Clinell Wipes vs Placebo |
Primary outcome
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.
3 secondary outcomes
Persistence of reduction in bacterial load at each test site.
Time frame: 30 minutes - 24 hours
Relative efficacy compared to a positive control
Time frame: 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.
Time frame: From application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Related trials for Antimicrobial Effect
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Recruiting
Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
Microbiome
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryl Bendel principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HEXI-PREP By Clinell Wipes and Chloraprep in people with Antimicrobial Effect, run by Gama Healthcare Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bacterial load at each test site. (time frame: 1 and 10 minutes after application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.