In-vivo Efficacy Study of Patient Pre-operative Preps

NCT01968707 | Completed Phase 3 Results

• 1 other identifier: EM-012760
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Reduction on Skin Flora Post-product Application

Keywords

surgical prep; CHG; IPA

Outcome Measures

Primary Outcomes (1)

• Responder Rate

  On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.

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

Secondary Outcomes (6)

• 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 minutes post-treatment

• Skin Flora Baseline for the Abdominal and Inguinal Region.

  Baseline

Study Arms (4)

ChloraPrep Hi-Lite Orange

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 Hi-Lite Orange

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

3M CHG/IPA Prep Tint 10.5 mL

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 Tint 10.5-mL

3M CHG/IPA Prep Tint 26-mL

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 Tint 26-mL

Interventions

ChloraPrep Hi-Lite Orange DRUG

Apply topically.

Also known as: ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA, ChloraPrep, Chlorhexidine Gluconate and Isopropyl alcohol

ChloraPrep Hi-Lite Orange

Normal saline DRUG

Apply topically.

Also known as: 0.9% Sodium Chloride, Sterile Saline, 0.9% NaCl, Saline

Normal Saline

3M CHG/IPA Prep Tint 10.5-mL DRUG

Apply topically.

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

3M CHG/IPA Prep Tint 10.5 mL

3M CHG/IPA Prep Tint 26-mL DRUG

Apply topically

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

3M CHG/IPA Prep Tint 26-mL

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 general 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 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Microbiotest

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Propanols; 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

• Muhammad H Bashir, MD, CCRP

  MICROBIOTEST

  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: October 21, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 2, 2024
• Results First Posted: June 9, 2021

Record last verified: 2024-09

Locations

US (1)