NCT03417661

An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes

An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Gama Healthcare Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.

Detailed description

HEXI-PREP by Clinell is a sterile single sachet wipe containing chlorhexidine gluconate and isopropyl alcohol. Both active ingredients are well-established ingredients commonly used for their disinfectant properties. This trial is designed to assess the superiority of HEXI-PREP by Clinell Wipe against a negative control, and also to demonstrate the relative efficacy of HEXI-PREP by Clinell WIpe against a similar commercially available product.

Conditions

• Antimicrobial Effect

Interventions

Type	Name	Description
DRUG	HEXI-PREP By Clinell Wipes	Sterile single sachet wipe containing 3ml solution.
DRUG	Chloraprep	Sterile applicator containing 3ml solution.
DRUG	Placebos	Sterile saline (0.9% w/v) wipe, containing 3ml of solution.

Timeline

• Start date: 2018-06-29
• Primary completion: 2019-06-06
• Completion: 2019-09-18
• First posted: 2018-01-31
• Last updated: 2020-07-22

Locations

1 site across 1 country: United Kingdom