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Surgical Site InfectionPhase 2NCT02296645

Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)

A Phase 2 study testing ZuraPrep and ChloraPrep 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

This is a randomized, paired-comparisons design where each subject receives two of the planned treatments. 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 and ChloraPrep
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Nov 2014to Jan 2015
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 to whom all of these conditions apply will be eligible for enrollment in this study:
  • Males and/or females, at least 18 years 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 (Appendix 14.6).
  • Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
  • Have Screening Day baseline counts of at least 1.3 x 103 CFU/cm2 per abdominal site (left and right) and 1.0 x 105 CFU/cm2 per groin site (left and right). For replacement subjects, have Screening Day baseline counts of at least 1.3 x 103 CFU/cm2 per abdominal site (left and right) and/or 1.0 x 105 CFU/cm2 per groin site (left and right).

Who cannot join

  • Subjects to whom any of these conditions apply will be excluded from this study:
  • 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 of the 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 chlorhexidine gluconate products.
  • Subjects who have a history of diabetes.
Show all 12Show fewer
  • Subjects who have a history of skin allergies.
  • Subjects who have a history of skin cancer within 6 inches of the applicable test areas.
  • Subjects who are pregnant, attempting pregnancy or nursing.
  • Subjects who have showered or bathed within 48 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 the 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 Laboratories

    Sterling, Virginia, 20164

Other trials in United States

About this study

Official title: A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™

This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.

Read the detailed description

ZuraPrep is being evaluated for safety and efficacy as a preoperative skin preparation against the Tentative Final Monograph (TFM) 10-minute end point recently revised by the FDA for the lower bound of a 95% confidence interval whereas there must be specific reductions of normal flora in the abdomen and groin areas. A positive control will be evaluated as well.

Being tested
ZuraPrep, ChloraPrep
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.

  • ZuraPrepDrug

    Also called Isopropyl alcohol 70%

    Apply topically.

  • ChloraPrepDrug

    Also called CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

    Apply topically.

Study groups in NCT02296645
Study groupRoleWhat they receive
ZuraPrepExperimentalIsopropyl alcohol (IPA) (70%)
Receives: Drug: ZuraPrep
ChloraPrepActive comparatorChlorhexidine 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.

  1. Reduction of skin flora

    The primary measure of antimicrobial efficacy is the log10 reduction of skin flora on the abdominal and groin sites 10 minutes following application of the study treatments relative to the Treatment Day baseline log10 counts.

    Measured: 10 minutes

Timeline

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

  1. First posted20 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

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 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296645
Sponsor's protocol ID
ZX-ZP-0055 (MBT# 865-101)
Status last verified
Mar 2015
First submitted
18 Nov 2014
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZuraPrep and ChloraPrep 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 12 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 14 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. 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 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 (time frame: 10 minutes). 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 NCT02296645.

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 14 Jul 2016.

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