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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Hollister Wound Care LLC
ClinicalTrials.gov Identifier:
NCT01396304
First received: July 14, 2011
Last updated: February 12, 2013
Last verified: February 2013

July 14, 2011
February 12, 2013
October 2011
February 2013   (final data collection date for primary outcome 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. [ Time Frame: Observations will be collected over 6 weeks for a total of 7 visits ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01396304 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Ulcer
  • Infection
  • Device: Restore Calcium Alginate Dressing
    Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
  • Device: AquaCel Ag Wound Dressing
    Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
  • Experimental: Restore Calcium Alginate Dressing Silver
    Restore Calcium Alginate Dressing Silver under compression wrap
    Intervention: Device: Restore Calcium Alginate Dressing
  • Active Comparator: Aquacel Ag Wound Dressing
    Aquacel Ag Wound Dressing under compression wrap
    Intervention: Device: AquaCel Ag Wound Dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01396304
4835-W
No
Hollister Wound Care LLC
Hollister Wound Care LLC
Not Provided
Study Director: Rita Kaurs, MSHSA MT NMT Hollister Incorporated
Hollister Wound Care LLC
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP