- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222896
Preoperative Chlorhexidine Gluconate (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 Chlorhexidine Gluconate (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 areas post CHG application.
Study Type
Interventional
Enrollment (Actual)
347
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
-
-
Virginia
-
Sterling, Virginia, United States, 20164
- MBT
-
-
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
|
2% CHG solution on cloth
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
Time Frame: 10 minutes, 6 hours, 8 hours
|
Percent of abdomen and groin sites that showed response (achieve a 2-Log and 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. |
10 minutes, 6 hours, 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: H Bashir, MBT
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
August 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
August 10, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimate)
August 22, 2014
Study Record Updates
Last Update Posted (Actual)
May 21, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R13-053
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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