Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Prevantics 3.15 % / 70 % Swabstick
Intervention description: Application of antiseptic drug to the inguinal area of the subjects; Application of antiseptic drug to the inguinal area of the subjects; Application of antiseptic drug to the inguinal area of the subjects; Application of antiseptic drug to the inguinal area of the subjects
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Samples are blinded to the Microbiology group, participant, sponsor (1 of 2) and statistician
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preventative

Summary:

      Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml
      Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test
      method for evaluation of preoperative, precatheterization or preinjection skin preparations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 18 years of age and of any race

          2. In good general health

          3. Read, understand and sign the Informed Consent Form (ICF)

          4. If female of child-bearing potential, are willing to use an acceptable method of
             contraception to prevent pregnancy (i.e. oral contraceptive, intra-uterine device,
             diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous
             relationship with a partner who has had a vasectomy)

          5. Female subjects of child-bearing potential, must have a negative Urine Pregnancy Test
             (UPT) on Treatment Day prior to any applications of the study products

        Exclusion Criteria:

          1. 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 washout conditioning period and during the test period

          2. Exposure of the test sites to strong detergents, solvents, or other irritants during
             the 14-day washout conditioning period and during the test period

          3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout
             conditioning period and during the test period

          4. Receive an irritation score of 1 (any redness, swelling, rash, or dryness present at
             any treatment area) for any individual skin condition prior to the Treatment Day
             baseline sample collection

          5. Use of systemic or topical antibiotic medications, steroid medications (other than for
             hormonal contraception or post-menopausal reasons), or any other product known to
             affect the normal microbial flora of the skin during the 14-day washout conditioning
             period and during the test period

          6. Known allergies or sensitivities to vinyl, latex (rubber), alcohols, metals, inks, or
             tape adhesives, or to common antibacterial agents found in soaps, lotions, or
             ointments, particularly isopropyl alcohol or chlorhexidine gluconate

          7. A medical diagnosis of a physical condition, such as a current or recent severe
             illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapses,
             congenital heart disease, internal prostheses, or any immunocompromised conditions
             such as AIDS (or HIV positive)

          8. Pregnancy, plans to become pregnant within the washout and test periods of the study,
             or nursing a child

          9. Any tattoos or scars within 2" (5.08 cm) of the test sites

         10. Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders
             within 6" on or around the test sites

         11. A currently active skin disease or inflammatory skin condition (for example, contact
             dermatitis) anywhere on the body that, in the opinion of the Consulting Physician or
             PI, would compromise subject safety or study integrity

         12. Showering, bathing, or swimming within the 72-hour period prior to sampling for
             Treatment Day, and throughout the test period

         13. Participation in another clinical study in the past 30 days or current participation
             in another clinical study at time of signing informed consent

         14. Any medical condition or use of any medications that, in the opinion of the PI, should
             preclude participation

         15. Unwillingness to fulfill the performance requirements of the study.