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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

Brief Summary:
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Condition or disease Intervention/treatment Phase
Surgery Drug: Chlorhexidine Gluconate Other: Vehicle Drug: DynaHex-2 Phase 3

Detailed Description:
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

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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

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Vehicle Cloth
Excipients on cloth
Other: Vehicle
Excipients of CHG product only.
Other Name: Control

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




Primary Outcome Measures :
  1. 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.




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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
Results First Posted: April 30, 2021
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data to be shared with FDA
Keywords provided by Medline Industries:
Preoperative surgical skin preparation
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents