Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

NCT ID: NCT02530541

Last Updated: 2021-04-30

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

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CHG 1 min

1 min application time

Group Type EXPERIMENTAL

CHG

Intervention Type DRUG

Varied application times

CHG 2 min

2 min application time

Group Type EXPERIMENTAL

CHG

Intervention Type DRUG

Varied application times

Comparator CHG

Marketed CHG

Group Type ACTIVE_COMPARATOR

CHG

Intervention Type DRUG

Varied application times

Interventions

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CHG

Varied application times

Intervention Type DRUG

Other Intervention Names

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Chlorhexidine Gluconate

Eligibility Criteria

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Inclusion Criteria

* Healthy
* No dermatological conditions

Exclusion Criteria

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Esther Campbell

Role: PRINCIPAL_INVESTIGATOR

Bioscience Labs

Other Identifiers

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R14-015

Identifier Type: -

Identifier Source: org_study_id

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