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

NCT ID: NCT03681990

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2017-07-04

Brief Summary

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

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.

Conditions

Surgical Skin Preparation; Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3M CHG/IPA Prep

Intervention Type: DRUG

Apply topically to intact skin

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.

Group Type: EXPERIMENTAL

3M CHG/IPA Prep

Intervention Type: DRUG

Apply topically to intact skin

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.

Group Type: EXPERIMENTAL

3M CHG/IPA Prep

Intervention Type: DRUG

Apply topically to intact skin

Interventions

3M CHG/IPA Prep

Apply topically to intact skin

Intervention Type: DRUG

Other Intervention Names

CHG 2%/IPA 70%; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; Chlorhexidine gluconate and Isopropyl alcohol

Eligibility Criteria

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,

Exclusion Criteria

• 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,
• 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.

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

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rozalia Olsavszky, MD

Role: PRINCIPAL_INVESTIGATOR

Eurofins/Evic

Locations

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

Bucharest, , Romania

Countries

Romania

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EM-012926

Identifier Type: -

Identifier Source: org_study_id