In-vivo Efficacy Study of Patient Pre-operative Preps

Solventum US LLC

Status and phase: Completed; Phase 3

Conditions: Bacterial Reduction on Skin Flora Post-product Application

Treatments: Drug: 3M CHG/IPA Prep Tint 26-mL; Drug: Normal saline; Drug: ChloraPrep Hi-Lite Orange; Drug: 3M CHG/IPA Prep Tint 10.5-mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968707

EM-012760

Details and patient eligibility

About

The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Full description

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Enrollment: 426 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects of any race
• Subjects in good general health
• Minimum skin flora baseline requirements on abdomen and groin

Exclusion criteria

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
• 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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426 participants in 4 patient groups, including a placebo group

ChloraPrep Hi-Lite Orange

Active Comparator group

Description:

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Treatment:

Drug: ChloraPrep Hi-Lite Orange

Normal Saline

Placebo Comparator group

Description:

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Treatment:

Drug: Normal saline

3M CHG/IPA Prep Tint 10.5 mL

Experimental group

Description:

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Treatment:

Drug: 3M CHG/IPA Prep Tint 10.5-mL

3M CHG/IPA Prep Tint 26-mL

Experimental group

Description:

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Treatment:

Drug: 3M CHG/IPA Prep Tint 26-mL