In Vivo Efficacy Study of Patient Preoperative Preps

NCT02203591 | Completed Phase 3 Results

• 1 other identifier: EM-013260
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Reduction Post-product Application

Keywords

surgical skin prep; CHG; IPA

Outcome Measures

Primary Outcomes (2)

• Responder Rate

  On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.

  baseline, 10 minutes post-product application and 6 hours post-product application

• Alternative Primary

  10 minute log reduction

  Baseline and 10 minutes

Secondary Outcomes (8)

• Reduction of Skin Flora 6 Hours Post-treatment

  6 hours

• Reduction of Skin Flora 10 Minutes Post-treatment

  10 minutes

• Skin Flora Recovery 6-hours Post-treatment

  6 hours post-treatment

• Skin Flora Recovery 10 Minutes Post-treatment

  10 minute post-product application

• Skin Flora Baseline for the Abdomen and Inguinal Region.

  Baseline

Study Arms (4)

3M CHG/IPA Prep C

EXPERIMENTAL

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

Drug: 3M CHG/IPA Prep C

3M CHG/IPA Prep CH

EXPERIMENTAL

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

Drug: 3M CHG/IPA Prep CH

ChloraPrep

ACTIVE COMPARATOR

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

Drug: ChloraPrep

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

3M CHG/IPA Prep C DRUG

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

Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%

3M CHG/IPA Prep C

3M CHG/IPA Prep CH DRUG

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

Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%

3M CHG/IPA Prep CH

ChloraPrep DRUG

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

Also known as: ChloraPrep Patient Preoperative Skin Preparation, ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG2%/IPA 70%, Chlorhexidine Gluconate and Isopropyl Alcohol

ChloraPrep

Normal Saline DRUG

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

Also known as: Sodium Chloride 0.9%, Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• 3M: lead

Study Sites (1)

BioScience Laboratories, Inc.

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate; 2-Propanol; Ethanol; Chromogranins; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Joan Paulson
• Organization: 3M

jepaulson@mmm.com

651-736-6583

Study Officials

• Jamie Miller, ADN

  Independent Consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Locations

US (1)