Surgical Site Infection
Conditions
Brief summary
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
Detailed description
This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.
Interventions
DRUGChloraPrep
The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.
The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.
The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.
OTHERZuraPrep without IPA
Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA
Sponsors
Zurex Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects may be of either sex, at least 18 years of age and of any race * Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back. * Subjects must be in good general health
Exclusion criteria
* Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate. * Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period. * Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period. * Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive. * Pregnancy, plans to become pregnant, breast-feeding * Any active skin rash or breaks in the skin of the back * Any sunburn or tattoos on the skin of the back * Current active skin disease or inflammatory skin condition including contact dermatitis * Participation in a clinical study in the past 7 days or current participation in another clinical study * Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation * Unwillingness to fulfill the performance requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scoring Scale (0-7) for Visual Evaluation of Skin Condition | 0-21 days post dose | Results from skin scores of ZuraPrep and ZuraPrep without IPA will be compared statistically, and both will be compared to the Positive Control (0.1% Sodium Lauryl Sulfate). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scoring Scale (0-7) for Visual Evaluation of Skin Condition | 0-21 days post dose | The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded. |
Countries
United States
Outcome results
None listed