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Completed

NCT Number: NCT02530554

Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

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Key information

Conditions

Surgery

Age range

18 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. Efficacy was assess using 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

Single application

Other names: Chlorhexidine Gluconate

Primary outcomes

  1. Log Change in Bacterial Flora on Abdomen and Groin

    Time frame: 10 min, 6 hr and 8 hr

    Change was calculated as the baseline time point minus the later time points over an 8 hour period.

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