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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04218110
Other study ID # ER19/232
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 11, 2020
Est. completion date March 31, 2020

Study information

Verified date October 2021
Source Professional Disposables International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 329
Est. completion date March 31, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Application of antiseptic drug to the inguinal area of the subjects
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Application of antiseptic drug to the inguinal area of the subjects
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Application of antiseptic drug to the inguinal area of the subjects
Prevantics 3.15 % / 70 % Swabstick
Application of antiseptic drug to the inguinal area of the subjects

Locations

Country Name City State
Romania Eurofins EVIC Bucharest

Sponsors (1)

Lead Sponsor Collaborator
Professional Disposables International, Inc.

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Bacterial Microflora in the Inguinal Area Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention 10 minutes
Secondary Change in Bacterial Microflora in the Inguinal Area Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention 30 seconds
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