- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291601
Preoperative CHG Cloth on Healthy Subjects
April 29, 2021 updated by: Medline Industries
Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.
Study Type
Interventional
Enrollment (Actual)
879
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Montana
-
Butte, Montana, United States, 59701
- BioScience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or Females
- 16 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Exclusion Criteria:
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle Cloth
Excipients on cloth
|
Excipients of CHG product only.
Other Names:
|
Experimental: Chlorhexidine Gluconate Cloth
2% CHG, single application
|
comparison with other CHG products
Other Names:
|
Active Comparator: Active Chlorhexidine gluconate solution
Dynahex 2% CHG
|
2% CHG solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
Time Frame: 10 minutes to 8 hours
|
Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline. |
10 minutes to 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: C Beausoleil, BS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
November 11, 2014
First Submitted That Met QC Criteria
November 13, 2014
First Posted (Estimate)
November 14, 2014
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R13-052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data to be shared with FDA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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