Surgical Skin PreparationPhase 3ZPNCT03782103
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
A Phase 3 study testing ZuraPrep Clear Solution and ChloraPrep in people with Surgical Skin Preparation, run by Zurex Pharma, Inc. at 1 site in United States.
Trial summary
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Skin Preparation
- What is being tested?
- ZuraPrep Clear Solution and ChloraPrep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 26 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of any race
- Subjects in good general health
- Minimum bacterial baseline requirements on abdomen and groin
- Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.
Who cannot join
- Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
- Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
- Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
- Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
- Subjects who are pregnant, attempting pregnancy or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Microbac Laboratories, Inc.
Sterling, Virginia, 20164
About this study
Official title: Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
Read the detailed description
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.
- Conditions
- Surgical Skin Preparation
- Being tested
- ZuraPrep Clear Solution, ChloraPrep, ZuraPrep Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZuraPrep Clear SolutionDrug
Also called Isopropyl alcohol 70%, ZP
Apply topically.
ChloraPrepDrug
Also called CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Apply topically.
ZuraPrep VehicleDrug
Also called Vehicle
Apply topically.
| Study group | Role | What they receive |
|---|---|---|
| ZuraPrep (70% IPA) | Experimental | Isopropyl alcohol (IPA) 70% Receives: Drug: ZuraPrep Clear Solution |
| ChloraPrep | Active comparator | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% Receives: Drug: ChloraPrep |
| ZuraPrep Vehicle | Placebo comparator | Zurex Prep without IPA Receives: Drug: ZuraPrep Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Reduction - Groin
A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.
Measured: 30 seconds post product application
Bacterial Reduction - Abdomen
A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.
Measured: 30 seconds post product application
Secondary outcomes (1)
Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
Bacterial counts should not exceed baseline on the abdomen or groin region
Measured: 6 hours post product applcation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start25 Jan 2019
- Primary completion12 May 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Skin PreparationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M H Bashir, MD, Principal investigator, Microbac Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782103
- Sponsor's protocol ID
- ZX-ZP-0092 / 865-107
- Acronym
- ZP
- Status last verified
- Jun 2021
- First submitted
- 18 Dec 2018
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep
- ClinicalTrials.gov ID
- NCT03782103
- Acronym / sponsor ID
- ZP / ZX-ZP-0092 / 865-107
- Conditions
- Surgical Skin Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Zurex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 21 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
Detailed description
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZuraPrep (70% IPA) | Experimental | Drug: ZuraPrep Clear SolutionIsopropyl alcohol (IPA) 70% |
| ChloraPrep | Active comparator | Drug: ChloraPrepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% |
| ZuraPrep Vehicle | Placebo comparator | Drug: ZuraPrep VehicleZurex Prep without IPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects of any race
- Subjects in good general health
- Minimum bacterial baseline requirements on abdomen and groin
- Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.
Key exclusion criteria (5 listed)
- Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
- Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
- Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
- Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
- Subjects who are pregnant, attempting pregnancy or nursing.
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 |
|---|---|---|
| ZuraPrep Clear SolutionAlso: Isopropyl alcohol 70%, ZPApply topically. | Drug | ZuraPrep (70% IPA) |
| ChloraPrepAlso: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%Apply topically. | Drug | ChloraPrep |
| ZuraPrep VehicleAlso: VehicleApply topically. | Drug | ZuraPrep Vehicle |
Primary outcome
Bacterial Reduction - Groin
Time frame: 30 seconds post product application
A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.
Bacterial Reduction - Abdomen
Time frame: 30 seconds post product application
A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.
1 secondary outcome
Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
Time frame: 6 hours post product applcation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
M H Bashir, MD principal investigator
Microbac Laboratories, Inc.
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 ZuraPrep Clear Solution and ChloraPrep in people with Surgical Skin Preparation, run by Zurex Pharma, Inc. at 1 site in United States.
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 4 inclusion and 5 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 8 Feb 2023. 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 States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bacterial Reduction - Groin (time frame: 30 seconds post product application). The study lists 2 primary outcomes in all. 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 8 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.