Evaluate the Impact of Drawtex in Venous Leg Ulcers
This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers|
- To investigate the impact of Drawtex on wound surface bioburden. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings
- Tolerance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To further investigate whether Drawtex
- Will have an overall benefit on the wound healing process.
- Patient's tolerance and acceptance of the dressings. The overall effect on wound healing, as expressed by percentages of necrosis, slough, granulation and/or epithelium at the wound surface.
- Condition of periwound skin
- Mobility restrictions, related to the dressing
- The number of dressings per dressing change, the number of dressing changes and the amount of nursing time involved
|Study Start Date:||October 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.
Device: Drawtex dressing
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers
Other Name: Beier Drawtex
Each subject is expected to participate in this study for a period of four weeks or until reepithelialization, whichever occurs first. Subjects may participate for an additional period of four weeks or until reepithelialization, whichever occurs first: this it to be decided by the investigator and will be determined by the accessibility of the patient (physical location) and the suitability of the wound to further treatment. The maximum time period for the study is 8 weeks. The minimum time frame is at least 4 week, or until reepithelialization occurs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319123
|United States, Texas|
|Southwest Regional Wound Care Center|
|Lubbock, Texas, United States, 79410|
|Principal Investigator:||Randall D Wolcott, M.D.||Southwest Regional Wound Care|