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

Hollister

Status and phase: Terminated; Phase 4

Conditions: Infection; Venous Ulcer

Treatments: Device: Restore Calcium Alginate Dressing; Device: AquaCel Ag Wound Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396304

4835-W

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Restore Calcium Alginate Dressing Silver

Experimental group

Description:

Restore Calcium Alginate Dressing Silver under compression wrap

Treatment:

Device: Restore Calcium Alginate Dressing

Aquacel Ag Wound Dressing

Active Comparator group

Description:

Aquacel Ag Wound Dressing under compression wrap

Treatment:

Device: AquaCel Ag Wound Dressing