NCT01368120

Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Covalon Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.

Detailed description

A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria. Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples. The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.

Conditions

• Skin Flora Infection

Interventions

Type	Name	Description
DEVICE	IV Clear™ Dressing	Polyurethane film, silicone adhesive dressing with chlorhexidine and silver
DEVICE	Tegaderm CHG™	Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
DEVICE	Silicone Vehicle Control Dressing	Polyurethane film with silicone adhesive dressing, without antimicrobials

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-07
• Last updated: 2015-04-16

Locations

1 site across 1 country: United States