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

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.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

- 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.