Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

Medline Industries14 enrolled

Overview

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

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Surgery

Interventions

CHGDRUG

Single application

Eligibility

Sex: ALLMin age: 18 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 Change in Bacterial Flora on Abdomen and Groin

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

Time frame: 10 min, 6 hr and 8 hr

Data from ClinicalTrials.gov

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