Clinical trial NCT01396304: Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
Official title: Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Ulcer
Infection
Keywords: leg ulcer
infection
closure
wound dressings
Lead sponsor: Hollister Wound Care LLC
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Observations will be collected over 6 weeks for a total of 7 visits
Secondary outcomes:
measure: The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.
timeFrame: Observations will be collected over 6 weeks in a total of 7 visits.
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Palms of Pasadena Hospital
state: Florida
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Holmdel
country: United States
facility: Bayshore Community Hospital
state: New Jersey
city: Dunmore
country: United States
facility: Wound Institute & Research Center
state: Pennsylvania
city: Bellevue
country: United States
facility: Lake Washington Vascular Surgeons
state: Washington
Study officials:
affiliation: Hollister Incorporated
name: Rita Kaurs, MSHSA MT NMT
role: STUDY_DIRECTOR
References: