Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances

Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Drug: Prevantics 3.15 % / 70 % Swabstick

• Study Type: Interventional
• Enrollment (Actual): 329
• 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

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

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 applicator. 26ml volume. Single use.	Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Application of antiseptic drug to the inguinal area of the subjects; Other Names: Project X 5.1ml
EXPERIMENTAL: Project X 10.5ml; 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.	Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Application of antiseptic drug to the inguinal area of the subjects; Other Names: Project X 5.1ml
EXPERIMENTAL: Project X 5.1ml; 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.	Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic; Application of antiseptic drug to the inguinal area of the subjects; Other Names: Project X 5.1ml
ACTIVE_COMPARATOR: Prevantics Maxi Swabstick; 3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.	Drug: Prevantics 3.15 % / 70 % Swabstick; Application of antiseptic drug to the inguinal area of the subjects; Other Names: Prevantics Maxi Swabstick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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 11, 2020
• Primary Completion (ACTUAL): March 10, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (ACTUAL): January 6, 2020

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

• Keywords: Preventative
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Physiological Effects of Drugs; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local
• Other Study ID Numbers: ER19/232

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
• product manufactured in and exported from the U.S.: No