NCT01396304

Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hollister Wound Care LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.

Conditions

• Venous Ulcer
• Infection

Interventions

Type	Name	Description
DEVICE	Restore Calcium Alginate Dressing	Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
DEVICE	AquaCel Ag Wound Dressing	Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-07-18
• Last updated: 2013-02-15

Locations

5 sites across 1 country: United States