Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

September 1, 2020 updated by: Medline Industries

Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Bio High Tech SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or Females
  • 18 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle Cloth
Excipients on cloth
Other: Vehicle
Excipients of CHG product only
Other Names:
  • Control
Experimental: Chlorhexidine Gluconate Cloth
2% CHG, single application
Drug: Chlorhexidine gluconate
2% CHG solution on cloth
Other Names:
  • CHG
Active Comparator: Active Chlorhexidine gluconate solution
Dynahex 2% CHG
Drug: DynaHex-2
2% CHG solution
Other Names:
  • CHG 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
Time Frame: 10 minutes, 6 hours, 8 hours
Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.
10 minutes, 6 hours, 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Investigators

  • Principal Investigator: R Olsavcszky, MD, S.C. BIO HIGH TECH S.R.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

August 16, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be shared with FDA.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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