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

NCT01396304 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-02-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hollister Wound Care LLC

    lead INDUSTRY

Principal Investigators

  • Rita Kaurs, MSHSA MT NMT · Hollister Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396304 on ClinicalTrials.gov