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Completed

NCT Number: NCT02526667

Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

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

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bio High Tech SRL

Bucharest, Romania

About this study

Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (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
  • 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

Treatment and study plan

Chlorhexidine gluconate

Drug

2% CHG solution on cloth

Other names: CHG

DynaHex-2

Drug

2% CHG solution

Other names: CHG 2%

Vehicle

Other

Excipients of CHG product only

Other names: Control

Primary outcomes

  1. 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.

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
2015
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2015
Registry last updated
Sep 28, 2020

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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