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Completed

NCT Number: NCT02530528

Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

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

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Key information

Conditions

Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • No dermatological conditions

Exclusion criteria

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

Treatment and study plan

CHG

Drug

Varied application times

Other names: Chlorhexidine Gluconate

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2015
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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