Status:

COMPLETED

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Lead Sponsor:

Medline Industries

Conditions:

Surgery

Eligibility:

All Genders

16+ years

Phase:

PHASE3

Brief Summary

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Detailed Description

For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed...

Eligibility Criteria

Inclusion

  • Free of skin disorders
  • Signed consent

Exclusion

  • Allergies to latex
  • Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
  • severe illness
  • Pregnant (females)

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2015

Estimated Enrollment :

249 Patients enrolled

Trial Details

Trial ID

NCT02224625

Start Date

August 1 2014

End Date

June 1 2015

Last Update

March 9 2017

Active Locations (1)

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BioScience Laboratories

Butte, Montana, United States, 59701