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Preoperative CHG Cloth (2)

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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

Brief Summary:
Demonstrate the reduction of bacteria on the skin.

Condition or disease Intervention/treatment Phase
Surgical Skin Preparation Drug: Chlorhexidine Gluconate Other: Vehicle Drug: 2% Chlorhexidine Gluconate Solution Phase 3

Detailed Description:
Examine the antimicrobial cloth effects on bacteria of the abdomen and groin area.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 879 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: Chlorhexidine Gluconate Cloth
2% CHG, single application
Drug: Chlorhexidine Gluconate
comparison with other CHG products

Placebo Comparator: Vehicle Cloth
Excipients on cloth
Other: Vehicle
Cloth with Excipients no CHG

Active Comparator: Active Chlorhexidine gluconate solution
Dynahex 2% CHG
Drug: 2% Chlorhexidine Gluconate Solution
CHG solution
Other Name: DynaHex




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assess the side effects on the skin [ Time Frame: 10 min to 8 hours ]
    Treated skin will be assessed for any irritation.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02291601


Locations
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United States, Montana
BioScience
Butte, Montana, United States, 59701
Sponsors and Collaborators
Medline Industries
Investigators
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Principal Investigator: C Beausoleil BS
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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02291601    
Other Study ID Numbers: R13-052
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents