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| Sponsor: | The University of Texas Health Science Center at San Antonio |
|---|---|
| Information provided by: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00686296 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Wounds |
Other: Taliderm™ Other: standard wet to dry dressing with gauze |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
| Official Title: | Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group II: 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.
|
Other: Taliderm™
Taliderm™ dressing application up to three applications
|
|
III: No Intervention
standard wet to dry dressing with gauze
|
Other: standard wet to dry dressing with gauze
wet to dry dressing standard of care
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|
group I: Active Comparator
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
|
Other: Taliderm™
taliderm™ dressing application once
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rachelle Jonas, RN, BSN | 210-567-3623 | babbittr@uthscsa.edu |
| Contact: Janet McCarthy, RN, CCRC | 210-567-3623 | mccarthyj@uthscsa.edu |
| United States, Texas | |
| University Hospital | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: John Myers, MD 210-567-3623 | |
| Principal Investigator: John G Myers, MD | |
| Sub-Investigator: Stephen M. Cohn, MD | |
| Principal Investigator: | John G Myers, MD | The University of Texas Health Science Center at San Antonio |
More Information
| Responsible Party: | University of Texas Health Science Center at San Antonio ( John G. Myers, M.D. ) |
| Study ID Numbers: | HSC-2007-0709-H |
| Study First Received: | May 26, 2008 |
| Last Updated: | June 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00686296 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
soft tissue abscess requiring incision and drainage |
