Evaluation 2% Chlorhexidine Gluconate

NCT ID: NCT03326726

Last Updated: 2023-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2016-11-18

Brief Summary

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Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.

Detailed Description

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Conditions

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Skin Coverage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chlorhexidine Gluconate

2% CHG

Group Type EXPERIMENTAL

2% CHG

Intervention Type DRUG

Chlorhexidine Gluconate

Interventions

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2% CHG

Chlorhexidine Gluconate

Intervention Type DRUG

Other Intervention Names

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Medline 2% CHG cloth

Eligibility Criteria

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Inclusion Criteria

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Bashir

Role: PRINCIPAL_INVESTIGATOR

Microbac Laboratories, Inc.

Other Identifiers

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R16-034

Identifier Type: -

Identifier Source: org_study_id

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