Efficacy Study of Patient Preoperative Preps In-vivo

Solventum US LLC

Status and phase: Completed; Phase 3

Conditions: Surgical Skin Preparation

Treatments: Drug: Normal saline; Drug: CHG/IPA Surgical skin preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04756154

EM-05-014624

Details and patient eligibility

About

The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

Full description

Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.

Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.

Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects of any race
• Subjects in good health
• Minimum skin flora baseline requirements on inguinal region

Exclusion criteria

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
• Topical antimicrobial exposure within 14 days prior to screening and treatment days
• Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 3 patient groups, including a placebo group

CHG/IPA Surgical skin preparation

Experimental group

Description:

Apply topically to the inguinal region for 2 minutes

Treatment:

Drug: CHG/IPA Surgical skin preparation

CHG/IPA Film-Forming Surgical skin preparation

Active Comparator group

Description:

Apply topically to the inguinal region for 2 minutes

Treatment:

Drug: CHG/IPA Surgical skin preparation

Normal saline

Placebo Comparator group

Description:

Apply topically to the inguinal region for 2 minutes

Treatment:

Drug: Normal saline