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Trial record 97 of 10364 for:    Anti-Infective Agents AND Bacterial

In-vivo Efficacy Study of Patient Preoperative Preps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01968356
Recruitment Status : Terminated (Study discontinued due to data quality issues.)
First Posted : October 24, 2013
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:
The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdomen and inguinal regions of human subjects.

Condition or disease Intervention/treatment Phase
Skin Flora Bacterial Reduction Post-product Application Drug: 3M CHG/IPA Prep Colorless Drug: 3M CHG/IPA Prep Tint Drug: ChloraPrep CHG/IPA Hi-Lite Orange Tint Other: Normal Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 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 : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3M CHG/IPA Prep Colorless
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
Drug: 3M CHG/IPA Prep Colorless
Apply topically.
Other Names:
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • CHG 2% / IPA 70%

Experimental: 3M CHG/IPA Prep Tint
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
Drug: 3M CHG/IPA Prep Tint
CHG 2%/IPA 70%
Other Name: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Active Comparator: ChloraPrep CHG/IPA Hi-Lite Orange Tint
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
Drug: ChloraPrep CHG/IPA Hi-Lite Orange Tint
Apply topically.
Other Name: CHG 2%/IPA 70%

Placebo Comparator: Normal Saline
0.9% normal saline with applicator
Other: Normal Saline
Apply topically.
Other Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. A 2-log per cm2 bacterial reduction on the abdomen region and a 3-log per cm2 bacterial reduction on the inguinal region. [ Time Frame: 10 minutes post-product application ]
  2. Skin flora does not return to baseline on the abdomen and inguinal region. [ Time Frame: 6 hour post-product application ]

Secondary Outcome Measures :
  1. Safety as assessed by Skin Irritation scores and Adverse Events [ Time Frame: 10 minute to 6 hours post-product application ]


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 general 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 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

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): NCT01968356


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: Robert R McCormack, BS BioScience Laboratories, Inc.

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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01968356     History of Changes
Other Study ID Numbers: EM-012759
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

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