| May 26, 2008 |
| June 20, 2009 |
| December 2008 |
| December 2009 (final data collection date for primary outcome measure) |
| The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits. [ Time Frame: two and three weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00686296 on ClinicalTrials.gov Archive Site |
| occurence of wound infection [ Time Frame: two and three weeks ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds |
| Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds |
To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage. |
| |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
| Wounds |
- Other: Taliderm™
- Other: standard wet to dry dressing with gauze
|
- Active Comparator: Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing. Gauze dressing changes will continue per standard of care until the scheduled follow-up visits (first or second visit). At the scheduled follow-up visits, the subject will have a Taliderm™ dressing applied and left in place until the next scheduled dressing change (up to eight hours), then will continue standard of care wet to dry gauze dressing changes until next scheduled follow-up visit.
- No Intervention: standard wet to dry dressing with gauze
- Active Comparator: Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
|
| |
| |
| Recruiting |
| 120 |
|
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension
- Wound will require serial dressing changes
- Greater than or equal to 18 years of age
- Ability to obtain informed consent
Exclusion Criteria:
- Inability to obtain informed consent
- Pregnancy
- Prisoner
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00686296 |
| John G. Myers, M.D., University of Texas Health Science Center at San Antonio |
| HSC-2007-0709-H |
| The University of Texas Health Science Center at San Antonio |
|
| Principal Investigator: |
John G Myers, MD |
The University of Texas Health Science Center at San Antonio |
|
|
| The University of Texas Health Science Center at San Antonio |
| June 2009 |