Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

NCT ID: NCT02222896

Last Updated: 2021-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-31

Brief Summary

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Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed Description

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Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Chlorhexidine Gluconate Cloth

2% CHG, single application

Group Type EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type DRUG

2% CHG solution on cloth

Vehicle Cloth

Excipients on cloth

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Excipients of CHG product only

Active Chlorhexidine gluconate solution

Dynahex 2% CHG

Group Type ACTIVE_COMPARATOR

DynaHex-2

Intervention Type DRUG

2% CHG solution

Interventions

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Chlorhexidine Gluconate

2% CHG solution on cloth

Intervention Type DRUG

Vehicle

Excipients of CHG product only

Intervention Type OTHER

DynaHex-2

2% CHG solution

Intervention Type DRUG

Other Intervention Names

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CHG Control CHG 2%

Eligibility Criteria

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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
Minimum Eligible Age

16 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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H Bashir

Role: PRINCIPAL_INVESTIGATOR

MBT

Locations

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MBT

Sterling, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R13-053

Identifier Type: -

Identifier Source: org_study_id

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