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| Name | Class |
|---|---|
| Beier Drawtex Healthcare, (PTY). Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wound dressing | Other | The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drawtex dressing | Device | The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the impact of Drawtex on wound surface bioburden. | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | To further investigate whether Drawtex
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall D Wolcott, M.D. | Southwest Regional Wound Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2013 | |
| Reset | Apr 12, 2013 | |
| Release | May 15, 2014 | |
| Reset | Jun 16, 2014 | |
| Release | Nov 11, 2014 | |
| Reset | Nov 19, 2014 | |
| Release | May 27, 2015 | |
| Reset | May 28, 2015 | |
| Release | Jun 3, 2015 | |
| Reset | Jun 4, 2015 | |
| Release | Dec 11, 2015 | |
| Reset | Jan 14, 2016 | |
| Release | Jun 8, 2016 | |
| Reset | Jul 19, 2016 | |
| Release | Sep 6, 2018 | |
| Reset | Oct 3, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2013 | Apr 12, 2013 | |||
| May 15, 2014 |
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| 2 years |
| Jun 16, 2014 |
| Nov 11, 2014 | Nov 19, 2014 |
| May 27, 2015 | May 28, 2015 |
| Jun 3, 2015 | Jun 4, 2015 |
| Dec 11, 2015 | Jan 14, 2016 |
| Jun 8, 2016 | Jul 19, 2016 |
| Sep 6, 2018 | Oct 3, 2018 |