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OpenTrials
Completed

NCT Number: NCT02291601

Preoperative CHG Cloth on Healthy Subjects

Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Completed

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Key information

Conditions

Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BioScience

Butte, Montana, 59701, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

comparison with other CHG products

Other names: CHG

Vehicle

Other

Excipients of CHG product only.

Other names: Control

DynaHex-2

Drug

2% CHG solution

Other names: CHG 2% Solution

Primary outcomes

  1. Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites

    Time frame: 10 minutes to 8 hours

    Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline.

    Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2014
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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