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Preoperative CHG Cloth (2)

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: NCT02291601
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date December 8, 2015
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: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative CHG Cloth (2)
Official Title  ICMJE Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Brief Summary Demonstrate the reduction of bacteria on the skin.
Detailed Description Examine the antimicrobial cloth effects on bacteria of the abdomen and groin area.
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 Surgical Skin Preparation
Intervention  ICMJE
  • Drug: Chlorhexidine Gluconate
    comparison with other CHG products
  • Other: Vehicle
    Cloth with Excipients no CHG
  • Drug: 2% Chlorhexidine Gluconate Solution
    CHG solution
    Other Name: DynaHex
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: 2% Chlorhexidine Gluconate Solution
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 Not Provided
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 December 2015

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