Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml 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, Pennsylvania, 2015

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • Bioscience Laboratories Inc

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:

• Subjects may be of either sex, at least 18 years of age, and of any race.
• Subjects must be able to read and understand English.
• Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study, all located in the separate Informed Consent documents.
• Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
• Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.
• Subjects must have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos, scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such as dry scabs or warts, may be admitted at the discretion of the Principal Investigator, Subinvestigators, or Consulting Physicians.

Exclusion Criteria:

• Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate or ethanol.
• Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
• Use of systemic or topical antibiotic medications during the 14-day pre-test period through completion of testing on the single test day.
• Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications, during the 14-day pre-test period through completion of testing on the single test day. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
• Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
• Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test period of the study, or nursing a child. Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
• Current participation or participation in a clinical study in the past 14 days.
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator or consulting physicians, would preclude participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• 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 applicator. 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 applicator. 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. 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 administration of the intervention	30 seconds
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	10 minutes
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	6 hours
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	30 seconds
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	10 minutes
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	6 hours

Collaborators and Investigators

• Sponsor: Professional Disposables International, Inc.
• Investigators: Principal Investigator: Collette Duley, BioScience Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1810480-103

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