In-vivo Efficacy Study of Patient Preoperative Preps

Solventum US LLC

Status and phase: Terminated; Phase 3

Conditions: Skin Flora Bacterial Reduction Post-product Application

Treatments: Drug: 3M CHG/IPA Prep Tint; Drug: Saline; Drug: 3M CHG/IPA Prep Colorless; Drug: ChloraPrep

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968356

EM-012759

Details and patient eligibility

About

The purpose of this study is to evaluate 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: 171 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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171 participants in 4 patient groups, including a placebo group

3M CHG/IPA Prep Colorless

Experimental group

Description:

Applied 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 Colorless

3M CHG/IPA Prep Tint

Experimental group

Description:

Applied 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

ChloraPrep Hi-Lite Orange

Active Comparator group

Description:

Applied 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

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline