Preoperative CHG Cloth on Healthy Subjects

Phase 3CompletedNCT02291601

Medline Industries879 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

879

Conditions

Surgery

Interventions

Chlorhexidine GluconateDRUG

comparison with other CHG products

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)

BioScience

Butte, Montana, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 10 minutes to 8 hours

Data from ClinicalTrials.gov

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