Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

Medline Industries

Status and phase: Completed; Phase 2; Phase 1

Conditions: Surgery

Treatments: Drug: CHG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02530528

R13-042

Details and patient eligibility

About

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

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 16+ 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: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 4 patient groups

2% CHG 1 min

Experimental group

Description:

single administration, 1 min application time

Treatment:

Drug: CHG

2% CHG 2 min

Experimental group

Description:

single administration, 2 min application time

Treatment:

Drug: CHG

2% CHG 3 min

Experimental group

Description:

single administration, 3 min application time

Treatment:

Drug: CHG

Comparator 2% CHG

Active Comparator group

Description:

Single administration, Marketed CHG

Treatment:

Drug: CHG