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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01396304
• Other study ID #: 4835-W
• Status: Terminated
• Phase: Phase 4
• First received: July 14, 2011
• Last updated: February 12, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Hollister Wound Care LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is 18 years or older; male or female.

2. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.

3. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.

4. Has an ankle brachial index (ABI) >0.8.

5. Has a venous ulcer with duration less than 24 months.

6. 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

7. Is currently using Profore as their standard of care.

8. Has not received antibiotics for 6 weeks prior to enrollment.

Exclusion Criteria

1. Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).

2. Is currently on antibiotics.

3. Has a negative venous duplex.

4. Is unable to tolerate 4 layer compression.

5. Is unable to continue contact with the investigator for a period of at least two weeks.

6. Is unwilling or unable to comply with the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• Restore Calcium Alginate Dressing
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
• AquaCel Ag Wound Dressing
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Locations

Country	Name	City	State
United States	Lake Washington Vascular Surgeons	Bellevue	Washington
United States	Wound Institute & Research Center	Dunmore	Pennsylvania
United States	Bayshore Community Hospital	Holmdel	New Jersey
United States	LSU Health Sciences Center	Shreveport	Louisiana
United States	Palms of Pasadena Hospital	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Wound Care LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Observations will be collected over 6 weeks for a total of 7 visits	No
Secondary	The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.		Observations will be collected over 6 weeks in a total of 7 visits.	No