Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

Phase 3CompletedNCT02222896

Medline Industries347 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

347

Conditions

Surgery

Interventions

Chlorhexidine GluconateDRUG

2% CHG solution on cloth

VehicleOTHER

Excipients of CHG product only

DynaHex-2DRUG

2% CHG solution

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MBT

Sterling, Virginia, United States

Outcomes

Primary Outcomes

Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin

Percent of abdomen and groin sites that showed response (achieve a 2-Log and 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.

Time frame: 10 minutes, 6 hours, 8 hours

Data from ClinicalTrials.gov

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