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

NCT ID: NCT03861780

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2019-06-06

Brief Summary

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

Conditions

Bacteria Microflora Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Project X 26ml

Intervention Type: DRUG

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

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.

Group Type: EXPERIMENTAL

Project X 5.1ml

Intervention Type: DRUG

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Prevantics Maxi Swabstick

3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use.

Group Type: ACTIVE_COMPARATOR

Prevantics Maxi Swabstick

Intervention Type: DRUG

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Interventions

Project X 26ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Intervention Type: DRUG

Project X 5.1ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Intervention Type: DRUG

Prevantics Maxi Swabstick

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Professional Disposables International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Collette Duley

Role: PRINCIPAL_INVESTIGATOR

BioScience Laboratories, Inc.

Locations

Bioscience Laboratories Inc

Bozeman, Montana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1810480-103

Identifier Type: -

Identifier Source: org_study_id