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Trial record 99 of 10353 for:    Anti-Infective Agents AND Bacterial

In Vivo Preoperative Skin Preparation Persistence

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ClinicalTrials.gov Identifier: NCT03155178
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:
The objective of the study is to demonstrate persistent effect of the CHG/IPA Prep on skin flora of the abdomen and inguinal regions of human subjects.

Condition or disease Intervention/treatment Phase
Bacterial Recovery of Skin Flora Post-product Application Drug: 3M CHG/IPA Prep Drug: ChloraPrep Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : April 25, 2017


Arm Intervention/treatment
Experimental: 3M CHG/IPA Prep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: 3M CHG/IPA Prep
Apply topically applied to intact skin.
Other Names:
  • CHG 2%/IPA 70%
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: ChloraPrep
Apply topically applied to intact skin.
Other Names:
  • CHG 2%/IPA 70%
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%




Primary Outcome Measures :
  1. Primary Assessment of Antimicrobial Persistence [ Time Frame: Pre-treatment (baseline), 10-minutes post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment ]
    Log10/cm2 reduction of skin flora, relative to pre-treatment (baseline) log10/cm2, at 4 defined post-treatment sampling times.


Secondary Outcome Measures :
  1. Secondary Assessment of Antimicrobial Persistence [ Time Frame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment ]
    Log10/cm2 reduction of skin flora, relative to 10-minute post-treatment log10/cm2, at 3 defined post-treatment sampling times.



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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

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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT03155178     History of Changes
Other Study ID Numbers: EM-05-013953
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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