Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

Medline Industries

Status and phase: Completed; Phase 2; Phase 1

Conditions: Surgery

Treatments: Drug: CHG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02530554

R15-028

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• No dermatological conditions

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

CHG Cloth

Experimental group

Description:

3 min application time

Treatment:

Drug: CHG

Comparator CHG

Active Comparator group

Description:

Marketed 2% CHG

Treatment:

Drug: CHG