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

NCT03681990 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EM-012926
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Skin Preparation; Surgical Procedure, Unspecified

Keywords

surgical skin prep; CHG; IPA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Outcome Evaluated by Skin Irritation Assessment

  Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes)

Study Arms (3)

3M CHG/IPA Prep / Center

EXPERIMENTAL

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

3M CHG/IPA Prep / Mid-peripheral

EXPERIMENTAL

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

3M CHG/IPA Prep / Peripheral

EXPERIMENTAL

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

Interventions

3M CHG/IPA Prep DRUG

Apply topically to intact skin

Also known as: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate and Isopropyl alcohol

3M CHG/IPA Prep / Center; 3M CHG/IPA Prep / Mid-peripheral; 3M CHG/IPA Prep / Peripheral

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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).
• 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,

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Eurofins Evic Romania/S.C. BIO HIGH TECH S.R.L.

Bucharest, 040256, Romania

Location

MeSH Terms

Interventions

Chromogranins; chlorhexidine gluconate; Ethanol; 2-Propanol

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Alcohols; Organic Chemicals; Propanols

Results Point of Contact

• Title: Joan E. Paulson
• Organization: 3M

jepaulson@mmm.com

651-736-6583

Study Officials

• Rozalia Olsavszky, MD

  Eurofins/Evic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: September 24, 2018
• Study Start: June 6, 2017
• Primary Completion: July 4, 2017
• Study Completion: July 4, 2017
• Last Updated: October 2, 2024
• Results First Posted: June 27, 2023

Record last verified: 2024-09

Locations

RO (1)