Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

Medline Industries27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Surgery

Interventions

CHGDRUG

Varied application times

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy * No dermatological conditions Exclusion Criteria: * Sensitivity to CHG * Sensitivity to natural latex rubber or adhesive skin products

Outcomes

Primary Outcomes

Log Reduction of Bacterial Flora on Abdomen and Groin Sites

Evaluate the Log Reduction of Normal Flora at various sites and timepoints

Time frame: 10 min, 6 hr and 8 hr

Data from ClinicalTrials.gov

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