Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

Medline Industries340 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 Chlorhexidine Gluconate (CHG) application.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

340

Conditions

Surgery

Interventions

Chlorhexidine gluconateDRUG

2% CHG solution on cloth

DynaHex-2DRUG

2% CHG solution

VehicleOTHER

Excipients of CHG product only

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bio High Tech SRL

Bucharest, Romania

Outcomes

Primary Outcomes

Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin

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.

Time frame: 10 minutes, 6 hours, 8 hours

Data from ClinicalTrials.gov

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