Surgical Site InfectionPhase 2ZX-ZP-0035NCT02221232
Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™
A Phase 2 study testing Chloraprep and ZuraPrep in people with Surgical Site Infection, run by Zurex Pharma, Inc. at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Chloraprep and ZuraPrep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of either sex, at least 18 years of age and of any race.
- Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria
- Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products
Who cannot join
- Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day pre-test conditioning period or during the test period.
- Use of topical or systemic antimicrobials, antibiotics, or steroids (other than hormones for contraception or post-menopausal indications), or any other product known to affect the normal microbial flora of the skin during the 14-day pre-test conditioning period or during the test period.
- 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.
- Known allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate (CHG), citric acid, methylene blue, methylparaben, propylparaben, or isopropyl alcohol.
- A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive).
- Subjects must be unable to become pregnant, or willing to use an acceptable method of contraception to prevent pregnancy, if female of child-bearing potential.
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- Inability to become pregnant would include subjects who are:
- Male
- Females unable to become pregnant (i.e., postmenopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, uterine ablation, or bilateral tubal ligation)
- Females of child-bearing potential but using acceptable methods of contraception, including one of the following methods that have been used for at least 2 weeks prior to Treatment Day Visit.
- Acceptable methods of contraception include one of the following methods:
- Systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study)
- Double barrier methods (condom with spermicide or diaphragm with spermicide)
- IUD
- Vasectomized partner; or
- Abstinence from sexual intercourse
- Any large tattoos, scars, active skin rashes, or breaks in the skin of the test sites.
- Dermatoses, cuts, lesions, or other skin disorders on or around the test sites
- A currently active skin disease or inflammatory skin condition (e.g., contact dermatitis) that, in the opinion of the Consulting Physician or Principal Investigator, would compromise subject safety or study integrity.
- Showering, bathing, or swimming within the 72 hour period prior to Baseline Day, the first Test Day, and throughout the test period.
- Participation in another clinical study in the past 30 days or current participation in another clinical study.
- Any medical condition or use of any medications that, in the opinion of the Medical Expert/Consulting Physician or Principal Investigator, should preclude participation.
- Unwillingness to fulfill the performance requirements of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
BioSciences Laboratories, Inc.
Bozeman, Montana, 59718
About this study
Official title: A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.
Read the detailed description
This is an open label pilot study to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied bilaterally to the skin of the abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness Testing of a Patient Preoperative Skin Preparation.
- Conditions
- Surgical Site Infection
- Being tested
- Chloraprep, ZuraPrep, ZuraPrep Vehicle
- Keywords
- ZuraPrep, Antimicrobial, Bio-Science Laboratories, Zurex Pharma, Surgical/Patient preoperative skin preparation
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraprepDrug
Also called 2% chlorhexidine gluconate / 70% Isopropyl alcohol, CHG 2% / IPA 70%
Apply topically.
ZuraPrepDrug
Also called Isopropyl alcohol 70%
Apply topically.
ZuraPrep VehicleDrug
Also called ZuraPrep without IPA, ZuraPrep Placebo
Apply topically.
| Study group | Role | What they receive |
|---|---|---|
| ZuraPrep Config 1 | Experimental | Isopropyl alcohol (IPA) 70% Standard scrub time. Receives: Drug: ZuraPrep |
| ZuraPrep Config 2 | Experimental | Isopropyl alcohol (IPA) 70% Half scrub time. Receives: Drug: ZuraPrep |
| ZuraPrep Vehicle | Placebo comparator | ZuraPrep without IPA Receives: Drug: ZuraPrep Vehicle |
| ChloraPrep | Active comparator | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% Receives: Drug: Chloraprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculations of mean log10 reductions from baseline populations
Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.
Measured: 0-24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: To assess product performance (test and reference products), move into further testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Beausoleil, Principal investigator, BioScience Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221232
- Sponsor's protocol ID
- 131112-103 (ZX-ZP-0035)
- Acronym
- ZX-ZP-0035
- Status last verified
- Nov 2014
- First submitted
- 18 Aug 2014
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
- ClinicalTrials.gov ID
- NCT02221232
- Acronym / sponsor ID
- ZX-ZP-0035 / 131112-103 (ZX-ZP-0035)
- Conditions
- Surgical Site Infection
- Keywords
- ZuraPrep, Antimicrobial, Bio-Science Laboratories, Zurex Pharma, Surgical/Patient preoperative skin preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To assess product performance (test and reference products), move into further testing.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zurex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.
Detailed description
This is an open label pilot study to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied bilaterally to the skin of the abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness Testing of a Patient Preoperative Skin Preparation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZuraPrep Config 1 | Experimental | Drug: ZuraPrepIsopropyl alcohol (IPA) 70% Standard scrub time. |
| ZuraPrep Config 2 | Experimental | Drug: ZuraPrepIsopropyl alcohol (IPA) 70% Half scrub time. |
| ZuraPrep Vehicle | Placebo comparator | Drug: ZuraPrep VehicleZuraPrep without IPA |
| ChloraPrep | Active comparator | Drug: ChloraprepChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects may be of either sex, at least 18 years of age and of any race.
- Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria
- Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products
Key exclusion criteria (23 listed)
- Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day pre-test conditioning period or during the test period.
- Use of topical or systemic antimicrobials, antibiotics, or steroids (other than hormones for contraception or post-menopausal indications), or any other product known to affect the normal microbial flora of the skin during the 14-day pre-test conditioning period or during the test period.
- 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.
- Known allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate (CHG), citric acid, methylene blue, methylparaben, propylparaben, or isopropyl alcohol.
- A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive).
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 |
|---|---|---|
| ChloraprepAlso: 2% chlorhexidine gluconate / 70% Isopropyl alcohol, CHG 2% / IPA 70%Apply topically. | Drug | ChloraPrep |
| ZuraPrepAlso: Isopropyl alcohol 70%Apply topically. | Drug | ZuraPrep Config 1, ZuraPrep Config 2 |
| ZuraPrep VehicleAlso: ZuraPrep without IPA, ZuraPrep PlaceboApply topically. | Drug | ZuraPrep Vehicle |
Primary outcome
Calculations of mean log10 reductions from baseline populations
Time frame: 0-24 hours post dose
Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.
Results and safety
The study was stopped early (reason given: To assess product performance (test and reference products), move into further testing.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
Chris Beausoleil principal investigator
BioScience 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 2 study testing Chloraprep and ZuraPrep in people with Surgical Site Infection, 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 3 inclusion and 23 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: stopped early, as of the sponsor's last update on 18 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: To assess product performance (test and reference products), move into further testing.). Results are not available in the source record.
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?
Calculations of mean log10 reductions from baseline populations (time frame: 0-24 hours post dose). 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 18 Jul 2016.