In Vivo Efficacy Study of Patient Preoperative Preps

3M Company

Status and phase: Completed; Phase 3

Conditions: Bacterial Reduction Post-product Application

Treatments: Drug: ChloraPrep; Drug: 3M CHG/IPA Prep C; Drug: Normal Saline; Drug: 3M CHG/IPA Prep CH

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203591

EM-013260

Details and patient eligibility

About

The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

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

Enrollment: 738 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 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 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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738 participants in 4 patient groups, including a placebo group

3M CHG/IPA Prep C

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 C

3M CHG/IPA Prep CH

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 CH

ChloraPrep

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

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