Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

Phase 1

Completed

• Conditions: Surgery
• Interventions: Drug: CHG

• Registration Number: NCT02530554
• Lead Sponsor: Medline Industries

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-16
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Results First Submitted: 2016-02-03
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Results First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy
• No dermatological conditions

Exclusion Criteria

• Sensitivity to CHG
• Sensitivity to natural latex rubber or adhesive skin products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHG Cloth	CHG	3 min application time
Comparator CHG	CHG	Marketed 2% CHG

Primary Outcome Measures

Name	Time	Method
Log Change in Bacterial Flora on Abdomen and Groin	10 min, 6 hr and 8 hr	Change was calculated as the baseline time point minus the later time points over an 8 hour period.