Comparative Study of Antimicrobial Effectiveness

Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1 ml Project X and Prevantics® Maxi Swabstick Following ASTM E1173

Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml 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, ASTM International, West Conshohocken, PA, 2015,

Study Overview

• Status: Completed
• Conditions: Bacterial Microflora Reduction
• Intervention / Treatment: Drug: Project X 26ml; Drug: Project X 5.1ml; Drug: Prevantics Maxi Swabstick

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 040256
    • Eurofins EVIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
6. Screening Day Baseline microbial counts are at least 3.11 colony forming units (CFU)/cm2 bilaterally from the skin of the abdomen, and 5.00 log10 colony forming units (CFU)/cm2 bilaterally from the skin of the groin (not applicable for Neutralization study)

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 (7-day for Neutralization study)
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 (7-day for Neutralization study)
3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period (7-day for Neutralization study)
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 Screening Day baseline or Treatment Day baseline sample collection or Neutralization study
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 (7-day for Neutralization study)
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 baseline screening, Treatment Day, and throughout the test period (not applicable for Neutralization study)
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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Project X 26ml; 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.	Drug: Project X 26ml; Application of antiseptic drug to the inguinal and abdomen areas of the subjects
EXPERIMENTAL: Project X 5.1ml; 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.	Drug: Project X 5.1ml; Application of antiseptic drug to the inguinal and abdomen areas of the subjects
ACTIVE_COMPARATOR: Prevantics Maxi Swabstick; 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.	Drug: Prevantics Maxi Swabstick; Application of antiseptic drug to the inguinal and abdomen areas of the subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	30 seconds
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	10 minutes
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	6 hours
Change in Bacterial Microflora on the Abdomen	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	30 seconds
Change in Bacterial Microflora on the Abdomen	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	10 minutes
Change in Bacterial Microflora on the Abdomen	Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention	6 hours

Collaborators and Investigators

• Sponsor: Professional Disposables International, Inc.
• Investigators: Principal Investigator: Rozalia Olsavszky, MD, EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ACTUAL): June 4, 2019
• Study Completion (ACTUAL): June 4, 2019

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (ACTUAL): January 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ER18/282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No