In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area

Evaluation of Microbial Population Reductions Within a Defined Product Coverage Area

This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; Surgical Skin Preparation
• Intervention / Treatment: Drug: 3M CHG/IPA Prep

Detailed Description

Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 040256
    • Eurofins Evic Romania/S.C. BIO HIGH TECH S.R.L.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male subjects of any race who are at least 18 years of age,
• Subjects must have an area on their back region to accommodate the treatment coverage area,
• Subjects must be in good general health,
• Subjects who satisfy all inclusion/exclusion criteria and will voluntarily read and sign the Informed Consent Form,
• Subjects who have good skin condition on the test sites,
• Subjects who are willing to report to the study facility approximately 72 hours prior to Screening or Treatment Day for clipping, if needed,
• Subjects who are willing to avoid showering and tub-bathing within 72 hours prior to Screening and Treatment Days, and
• Subjects who have Screening Day baseline counts of > 3.00 log10 per cm2 in each of the 3 sample sites (center, mid-peripheral and peripheral) in the treatment area (back region).

Exclusion Criteria:

• Participation in another clinical study in the past 30 days, current participation in another clinical study, or previous participation in this study,
• Has taken antihistamines in the 48 hours prior to Treatment Day,
• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas,
• A history of skin allergies,
• A history of skin cancer within 6 inches of the test areas,
• Known sensitivity to acrylate-, chlorhexidine gluconate-, or alcohol-containing products, or to medical tape, metals, natural rubber latex, vinyl, or skin-marking inks,
• A medical diagnosis with physical condition that may put the subject at risk, such as a current or recent severe illness, hepatitis, organ transplant, congestive heart disease, or any immunocompromised conditions, such as AIDS (or HIV positive),
• Any medical condition or use of any medications that, in the opinion of the Investigator, should preclude participation,
• Topical antimicrobial exposure within 14 days prior to Screening Day and throughout the study. Restrictions include, but are not limited to antimicrobial soaps, medicated shampoos, medicated lotions, antiperspirants/deodorants, perfumes, after shaves, and colognes,
• Use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin within 14 days prior to Screening Day and throughout the study,
• Exposure of the test areas to solvents, acids, bases, strong detergents, fabric softener-treated clothing, or other household chemicals within 14 days prior to Screening Day and throughout the study,
• Swimming in chemically treated pools or bathing in hot tubs, spas, or whirlpools within 14 days prior to Screening Day and throughout the study,
• Use of tanning beds, hot waxes, or depilatories (in the applicable test areas) within 14 days prior to Screening Day and throughout the study
• Bathing and showering within 72 hours prior to Screening Day and throughout the study, or
• Subject has used moisturizers or any topical treatment (e.g. lotion, sunscreen or shaving cream) on the test sites in the 24-hour period prior to Screening Day and Treatment Day participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M CHG/IPA Prep / Center; Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area.	Drug: 3M CHG/IPA Prep; Apply topically to intact skin; Other Names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%; Chlorhexidine gluconate and Isopropyl alcohol
Experimental: 3M CHG/IPA Prep / Mid-peripheral; Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area.	Drug: 3M CHG/IPA Prep; Apply topically to intact skin; Other Names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%; Chlorhexidine gluconate and Isopropyl alcohol
Experimental: 3M CHG/IPA Prep / Peripheral; Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area.	Drug: 3M CHG/IPA Prep; Apply topically to intact skin; Other Names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%; Chlorhexidine gluconate and Isopropyl alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.	The primary measure of efficacy is change in skin flora log10 CFU/cm^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.	Post-treatment sampling randomized as 10-minute or 13-minute post-product application

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome Evaluated by Skin Irritation Assessment	Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction.	Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes)

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Rozalia Olsavszky, MD, Eurofins/Evic

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: surgical skin prep; CHG; IPA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: EM-012926

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.: Yes