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

Primary Purpose

Venous Ulcer, Infection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Restore Calcium Alginate Dressing
AquaCel Ag Wound Dressing
Sponsored by
Hollister Wound Care LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring leg ulcer, infection, closure, wound dressings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Palms of Pasadena Hospital
  • LSU Health Sciences Center
  • Bayshore Community Hospital
  • Wound Institute & Research Center
  • Lake Washington Vascular Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Restore Calcium Alginate Dressing Silver

Aquacel Ag Wound Dressing

Arm Description

Restore Calcium Alginate Dressing Silver under compression wrap

Aquacel Ag Wound Dressing under compression wrap

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.

Full Information

First Posted
July 14, 2011
Last Updated
February 12, 2013
Sponsor
Hollister Wound Care LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01396304
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hollister Wound Care LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer, Infection
Keywords
leg ulcer, infection, closure, wound dressings

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restore Calcium Alginate Dressing Silver
Arm Type
Experimental
Arm Description
Restore Calcium Alginate Dressing Silver under compression wrap
Arm Title
Aquacel Ag Wound Dressing
Arm Type
Active Comparator
Arm Description
Aquacel Ag Wound Dressing under compression wrap
Intervention Type
Device
Intervention Name(s)
Restore Calcium Alginate Dressing
Intervention Description
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
Intervention Type
Device
Intervention Name(s)
AquaCel Ag Wound Dressing
Intervention Description
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is 18 years or older; male or female. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2. Has an ankle brachial index (ABI) >0.8. Has a venous ulcer with duration less than 24 months. 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 Is currently using Profore as their standard of care. Has not received antibiotics for 6 weeks prior to enrollment. Exclusion Criteria Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver). Is currently on antibiotics. Has a negative venous duplex. Is unable to tolerate 4 layer compression. Is unable to continue contact with the investigator for a period of at least two weeks. Is unwilling or unable to comply with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Kaurs, MSHSA MT NMT
Organizational Affiliation
Hollister Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Palms of Pasadena Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Bayshore Community Hospital
City
Holmdel
State/Province
New Jersey
ZIP/Postal Code
07733
Country
United States
Facility Name
Wound Institute & Research Center
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Lake Washington Vascular Surgeons
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

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

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