A Phase 4 interventional study of Restore Calcium Alginate Dressing and AquaCel Ag Wound Dressing in Venous Ulcer and Infection, sponsored by Hollister Wound Care LLC. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.
Sponsored by Hollister Wound Care LLC · Phase 4, Interventional, and Treatment
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.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 19 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →This is the only study on the registry with Hollister Wound Care LLC as lead sponsor.
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Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:
Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
Exclusion Criteria
Restore Calcium Alginate Dressing Silver under compression wrap
Device: Restore Calcium Alginate Dressing
Aquacel Ag Wound Dressing under compression wrap
Device: AquaCel Ag Wound Dressing
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
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.
Time frame: Observations will be collected over 6 weeks for a total of 7 visits
The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.
Time frame: Observations will be collected over 6 weeks in a total of 7 visits.
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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