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Trial of Preoperative Skin Preparation

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ClinicalTrials.gov Identifier: NCT02530541
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Brief Summary:
Pilot study to evaluate and compare activity of preoperative preparation with comparator

Condition or disease Intervention/treatment Phase
Healthy Drug: CHG Phase 1 Phase 2

Detailed Description:
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHG 1 min
1 min application time
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate

Experimental: CHG 2 min
2 min application time
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate

Active Comparator: Comparator CHG
Marketed CHG
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate




Primary Outcome Measures :
  1. Log Reduction of Bacterial Flora on the Abdomen and Groin [ Time Frame: 10 min, 6 hr and 8 hr ]
    Evaluate the Log Reduction of normal flora at various timepoints


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 10 min, 6 hr and 8 hr ]
    Compare the percent of treatment related adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • No dermatological conditions

Exclusion Criteria:

  • Sensitivity to CHG
  • Sensitivity to natural latex rubber or adhesive skin products

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02530541     History of Changes
Other Study ID Numbers: R14-015
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents