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Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

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ClinicalTrials.gov Identifier: NCT00686296
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
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 or disease Intervention/treatment Phase
Wounds Other: Taliderm™ Other: standard wet to dry dressing with gauze Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group II
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
standard wet to dry dressing with gauze
Other: standard wet to dry dressing with gauze
wet to dry dressing standard of care
Active Comparator: group I
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. occurence of wound infection [ Time Frame: two and three weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686296


Locations
United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: John G Myers, MD The University of Texas Health Science Center at San Antonio

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00686296     History of Changes
Other Study ID Numbers: HSC-2007-0709-H
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by The University of Texas Health Science Center at San Antonio:
soft tissue abscess requiring incision and drainage

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound