NCT01368146

Human Repeat Insult Patch Test of Wound Dressings

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Covalon Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

Detailed description

A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge). Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.

Conditions

• Skin Sensitization

Interventions

Type	Name	Description
DEVICE	IV Clear™	Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
DEVICE	Tegaderm CHG™	Polyurethane film with a 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: 2011-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-06-07
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States