Surgical Skin PreparationPhase 3NCT02831816
Clinical Evaluation of Patient Preoperative Prep
A Phase 3 study testing ZuraPrep 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 ZP Preoperative Prep 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 and ChloraPrep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to 3 Aug 2017
- 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 health.
- Minimum skin flora 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.
- 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
BioScience Laboratories, Inc.
Bozeman, Montana, 59718
About this study
Official title: Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
- Conditions
- Surgical Skin Preparation
- Being tested
- ZuraPrep, ChloraPrep, ZP Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZuraPrepDrug
Also called Isopropyl alcohol 70%, ZP
Apply topically.
ChloraPrepDrug
Also called CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Apply topically.
ZP VehicleDrug
Also called ZP without IPA
Apply topically.
| Study group | Role | What they receive |
|---|---|---|
| ZP (70% IPA) | Experimental | Isopropyl alcohol (IPA) 70% Receives: Drug: ZuraPrep |
| ChloraPrep | Active comparator | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% Receives: Drug: ChloraPrep |
| ZP Vehicle | Placebo comparator | ZP without IPA Receives: Drug: ZP Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Reduction
A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.
Measured: 10 minutes post product application
Bacterial Reduction - Abdomen
A 2-log per cm2 bacterial reduction on the abdomen region is considered a success.
Measured: 10 minutes post product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start3 Aug 2016
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831816
- Sponsor's protocol ID
- ZX-ZP-0074 / 150316-103
- Status last verified
- Jun 2021
- First submitted
- 11 Jul 2016
- Last updated
- 16 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.
PubMed 32131912
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
- ClinicalTrials.gov ID
- NCT02831816
- Acronym / sponsor ID
- ZX-ZP-0074 / 150316-103
- Conditions
- Surgical Skin Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Zurex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Posted 16 Jul 2021
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 ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZP (70% IPA) | Experimental | Drug: ZuraPrepIsopropyl alcohol (IPA) 70% |
| ChloraPrep | Active comparator | Drug: ChloraPrepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% |
| ZP Vehicle | Placebo comparator | Drug: ZP VehicleZP 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 health.
- Minimum skin flora 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 (3 listed)
- Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
- 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 |
|---|---|---|
| ZuraPrepAlso: Isopropyl alcohol 70%, ZPApply topically. | Drug | ZP (70% IPA) |
| ChloraPrepAlso: CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%Apply topically. | Drug | ChloraPrep |
| ZP VehicleAlso: ZP without IPAApply topically. | Drug | ZP Vehicle |
Primary outcome
Bacterial Reduction
Time frame: 10 minutes post product application
A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.
Bacterial Reduction - Abdomen
Time frame: 10 minutes post product application
A 2-log per cm2 bacterial reduction on the abdomen region is considered a success.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32131912Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 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 16 Jul 2021. 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 16 Jul 2021). 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 (time frame: 10 minutes 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?
On the ClinicalTrials.gov record for NCT02831816, which also lists 1 linked publication.
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 16 Jul 2021.