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Surgical Site InfectionPhase 3NCT02578771

Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

A Phase 3 study testing ZuraPrep with 70% IPA, ZuraPrep without 70% IPA and ChloraPrep CHG/IPA Teal Tint in people with Surgical Site Infection, run by Zurex Pharma, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. 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?
ZuraPrep with 70% IPA, ZuraPrep without 70% IPA and ChloraPrep CHG/IPA Teal Tint
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
123 participants
Where
1 siteUnited States
Study dates
Oct 2015to Jan 2016
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female volunteers, 18 years of age or older.
  • Are in good general health.
  • Have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
  • Cooperative and willing to follow Subject Instructions.
  • Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
  • Have acceptable Screening Day baseline counts (CFU/cm2).

Who cannot join

  • Topical or systemic antimicrobial exposure within 14 days prior to Screening Day. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, colognes, and topical or systemic antibiotics.
  • Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Screening Day.
  • Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Screening Day.
  • Contact with solvents, acids, bases, fabric softener-treated clothing or other household chemicals in the applicable test areas within 14 days prior to Screening Day.
  • Subjects who have a history of sensitivity to natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl alcohol, citric acid, methylene blue, methylparaben, propylparaben, or chlorhexidine gluconate products.
  • Subjects who have a history of skin allergies.
Show all 11Show fewer
  • Subjects who have a history of skin cancer within 6 inches of the applicable test areas.
  • Subjects who are pregnant, attempting pregnancy or nursing. For all females of child-bearing potential (<60 years of age), a urine pregnancy test will be performed prior to treatment on Treatment Day.
  • Subjects who have showered or bathed within 72 hours of the Screening Day or Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
  • Subjects who receive an irritation score of 1 for any individual skin condition prior to Screening Day baseline or Treatment Day baseline sample collection.
  • Participation in another clinical trial in the 30 days prior to Test Day of this study (treatment with test materials in this study), or be currently enrolled in another clinical trial, or has previously participated in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MicroBioTest

    Sterling, Virginia, 20164

Other trials in United States

About this study

Official title: Pilot Clinical Evaluation to Characterize the in Vivo Effects of Topically Applied ZuraPrep and ZuraPrep Vehicle

ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.

Read the detailed description

The single investigational test article, ZuraPrep solution is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin.

The primary objective of this study is to characterize the in vivo effects of the ZuraPrep test article compared to the positive reference control ChloraPrep, as well as to evaluate the ZuraPrep test vehicle to the negative control, Saline, using the newly proposed sampling intervals.

This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Treatments will be evaluated at 30 seconds, 10 minutes and 6 hour sampling intervals compared to baseline. Status will be calculated separately for the abdomen and groin for each side of the body.

Study duration for subjects - 3 to 4 weeks.

Being tested
ZuraPrep with 70% IPA, ZuraPrep without 70% IPA, ChloraPrep CHG/IPA Teal Tint, Normal Saline
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.

  • ZuraPrep with 70% IPADrug

    Also called 70% IPA

    Apply topically

  • ZuraPrep without 70% IPADrug

    Also called ZuraPrep Vehicle

    Apply topically. 0% IPA

  • ChloraPrep CHG/IPA Teal TintDrug

    Also called CHG 2% / IPA 70%

    Apply topically

  • Normal SalineOther

    Also called 0.85% Sodium Chloride (NaCl)

    Apply topically

Study groups in NCT02578771
Study groupRoleWhat they receive
ZuraPrep with 70% Isopropyl alcoholExperimentalTest Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep
Receives: Drug: ZuraPrep with 70% IPA; Drug: ChloraPrep CHG/IPA Teal Tint
ZuraPrep without 70% IPAExperimentalVehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline
Receives: Drug: ZuraPrep without 70% IPA; Other: Normal Saline
ChloraPrep Teal TintActive comparatorTest Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint
Receives: Drug: ZuraPrep with 70% IPA; Drug: ChloraPrep CHG/IPA Teal Tint
Normal Saline 0.85%Placebo comparatorVehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%
Receives: Drug: ZuraPrep without 70% IPA; Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment

    calculated as log-10 CFU responder rates from baseline

    Measured: 30 seconds

  2. Reduction of skin flora measured by 1994 TFM

    calculated as log-10 CFU reductions from baseline

    Measured: 10 minutes

Secondary outcomes (1)

  1. Skin flora measurement

    The bacterial counts should not exceed baseline at the 6 hour sampling time

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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, Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578771
Sponsor's protocol ID
ZX-ZP-0068 (MBT#865-104)
Status last verified
Jul 2017
First submitted
8 Oct 2015
Last updated
17 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZuraPrep with 70% IPA, ZuraPrep without 70% IPA and ChloraPrep CHG/IPA Teal Tint 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 6 inclusion and 11 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 17 Jul 2017. 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?

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 skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment (time frame: 30 seconds). 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 NCT02578771.

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 17 Jul 2017.

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