Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

April 28, 2021 updated by: Medline Industries

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

Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • No dermatological conditions

Exclusion Criteria:

  • Sensitivity to CHG
  • Sensitivity to natural latex rubber or adhesive skin products

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2% CHG 1 min
single administration, 1 min application time
Drug: CHG
Varied application times
Other Names:
  • Chlorhexidine Gluconate
Experimental: 2% CHG 2 min
single administration, 2 min application time
Drug: CHG
Varied application times
Other Names:
  • Chlorhexidine Gluconate
Experimental: 2% CHG 3 min
single administration, 3 min application time
Drug: CHG
Varied application times
Other Names:
  • Chlorhexidine Gluconate
Active Comparator: Comparator 2% CHG
Single administration, Marketed CHG
Drug: CHG
Varied application times
Other Names:
  • Chlorhexidine Gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
Time Frame: 10 min, 6 hr and 8 hr
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
10 min, 6 hr and 8 hr

Collaborators and Investigators

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

Sponsor

Medline Industries

Investigators

  • Principal Investigator: Bashir M Hamid, MD, Microbac Laboratories

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

February 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R13-042

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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