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In Vivo Efficacy Study of Patient Preoperative Preps

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ClinicalTrials.gov Identifier: NCT02203591
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
3M

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Reduction Post-product Application Drug: 3M CHG/IPA Prep C Drug: 3M CHG/IPA Prep CH Drug: ChloraPrep Drug: Normal Saline Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: 3M CHG/IPA Prep C
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
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Other Names:
  • Chlorhexidine Gluconate and Isopropyl Alcohol
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • CHG 2%/IPA 70%
Experimental: 3M CHG/IPA Prep CH
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
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Other Names:
  • Chlorhexidine Gluconate and Isopropyl Alcohol
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • CHG 2%/IPA 70%
Active Comparator: ChloraPrep
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
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Other Names:
  • ChloraPrep Patient Preoperative Skin Preparation
  • ChloraPrep One-Step
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • CHG2%/IPA 70%
  • Chlorhexidine Gluconate and Isopropyl Alcohol
Placebo Comparator: Normal Saline
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
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Other Names:
  • Sodium Chloride 0.9%
  • Saline


Outcome Measures
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Primary Outcome Measures :
  1. Responder Rate [ Time Frame: baseline, 10 minutes post-product application and 6 hours post-product application ]

    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.


  2. Alternative Primary [ Time Frame: Baseline and 10 minutes ]
    10 minute log reduction


Secondary Outcome Measures :
  1. Reduction of Skin Flora 6 Hours Post-treatment [ Time Frame: 6 hours ]
    Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application

  2. Reduction of Skin Flora 10 Minutes Post-treatment [ Time Frame: 10 minutes ]
    Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application

  3. Skin Flora Recovery 6-hours Post-treatment [ Time Frame: 6 hours post-treatment ]
    Log10/cm^2 recovery of skin flora at 6 hours following application of treatment

  4. Skin Flora Recovery 10 Minutes Post-treatment [ Time Frame: 10 minute post-product application ]
    Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.

  5. Skin Flora Baseline for the Abdomen and Inguinal Region. [ Time Frame: Baseline ]
    Log10/cm^2 baseline skin flora for abdominal and inguinal regions

  6. Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score [ Time Frame: Baseline ]
    Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.

  7. Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score [ Time Frame: 10 minutes post-treatment ]
    Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe

  8. Safety as Assessed by Skin Irritation Score [ Time Frame: 6 hours post-treatment ]
    Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203591


Locations
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United States, Montana
BioScience Laboratories, Inc.
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
3M
Investigators
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Principal Investigator: Jamie Miller, ADN Independent Consultant
More Information
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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02203591    
Other Study ID Numbers: EM-013260
First Posted: July 30, 2014    Key Record Dates
Results First Posted: November 23, 2020
Last Update Posted: November 23, 2020
Last Verified: October 2020
Keywords provided by 3M:
surgical skin prep
CHG
IPA
Additional relevant MeSH terms:
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Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents