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Preoperative CHG Cloth on Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02291601
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE February 3, 2016
Results First Posted Date  ICMJE April 30, 2021
Last Update Posted Date April 30, 2021
Study Start Date  ICMJE October 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Count the number of bacteria on skin [ Time Frame: 10 minutes to 8 hours ]
Bacteria on the skin will be evaluated at time 0, 10 minutes, 6 hours and 8 hours after treatment.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Assess the side effects on the skin [ Time Frame: 10 min to 8 hours ]
Treated skin will be assessed for any irritation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative CHG Cloth on Healthy Subjects
Official Title  ICMJE Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Brief Summary Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
Detailed Description Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Surgery
Intervention  ICMJE
  • Drug: Chlorhexidine Gluconate
    comparison with other CHG products
    Other Name: CHG
  • Other: Vehicle
    Excipients of CHG product only.
    Other Name: Control
  • Drug: DynaHex-2
    2% CHG solution
    Other Name: CHG 2% Solution
Study Arms  ICMJE
  • Experimental: Chlorhexidine Gluconate Cloth
    2% CHG, single application
    Intervention: Drug: Chlorhexidine Gluconate
  • Placebo Comparator: Vehicle Cloth
    Excipients on cloth
    Intervention: Other: Vehicle
  • Active Comparator: Active Chlorhexidine gluconate solution
    Dynahex 2% CHG
    Intervention: Drug: DynaHex-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2015)
879
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2014)
375
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291601
Other Study ID Numbers  ICMJE R13-052
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data to be shared with FDA
Responsible Party Medline Industries
Study Sponsor  ICMJE Medline Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: C Beausoleil BS
PRS Account Medline Industries
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP